Total 11 job vacancies by 5PY US Quintiles, Inc.

Marketing Manager, Demand Generation

The Demand Generation Manager brings an innovative spirit and a deep focus on data in the design and implement of a comprehensive campaign marketing plan within IQVIA’s Research & Development Solutions (R&DS) Marketing team. The Manager will be the central point for driving campaigns globally, and to ensure marketing campaigns achieve their objectives. This role will partner with the various marketers to understand the audience and the solutions within the business unit in order develop compelling campaigns that drive demand for IQVIA’s RDS solutions. They will work with the Director of Digital Marketing to create, execute, and monitor the performance of marketing campaigns. 

Key responsibilities include:

• Collaborate with marketing teams to build prescriptive persona-based buyer journeys as the foundation for campaign strategy.
• Work with marketers across our team and in our company to ensure proper messaging, timing, and execution of multi-channel campaigns.
• Plan, launch, and fine-tune branding and lead generation campaigns to meet organizational objectives.
• Apply an experimentation mindset to marketing campaigns to drive, test, learn, and optimize. Continuously conduct A/B testing across all channels
• Identify campaign objective and KPIs while continuously monitoring campaign performance and make necessary adjustments for optimal results.
• Determine best digital, social, events and other tactics with the goal of optimizing campaign and channel performance (through KPIs such as MQL conversion, pipeline influence/attribution, web visits, social engagement etc.).
• Manage the campaign budget, allocating spend for creative, media, and production and ensuring each campaign delivers a strong ROI.
• Run reports on campaign performance which may include platforms such as Salesforce, Google Data Studio, Power BI, Khoros. Apply your analytical skills and use data to identify trends/insights to optimize performance.

Requirements:

• Bachelor's Degree required, preferably in Marketing.
• 4+ years of Marketing experience with experience in B2B Marketing from the CRO (Clinical Research Org.) or pharmaceutical industry most preferred, or life science B2B marketing experience.
• 2+ years of demand generation experience (Growth marketing, campaign management, media buying, lead/pipeline generation and/or similar) Data driven.
• Demonstrates a keen understanding and appreciation of metrics, have experience with A/B testing, and marketing program optimization.
• Ability to track and report on key metrics that measure performance in programs and campaigns inclusive of traffic, revenue, conversions, and ROI
• Experience with various productivity and office tools (Microsoft Office, Outlook, Teams, Smartsheet)
• Familiarity preferred with various marketing, sales, and analytics platforms (Eloqua, Salesforce, Khoros, GA4, Google Data Studio, Power BI).

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

*This Position is Remote in North America*

The IQVIA Cell and Gene Therapy Center of Excellence, a hub of CAGT clinical innovation, is growing! We are looking for exceptional Board-Certified physicians to join our team as a Medical Strategy Lead to help us expand our CAGT portfolio and advance this dynamic and rapidly expanding area of clinical development.

The CAGT Medical Strategy Lead is a subject matter expert with experience in clinical research and clinical trials who will be a champion for CAGT across IQVIA.

The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise. The Medical Strategy Lead will be charged with using his/her clinical, scientific, and operational knowledge to harness the vast IQVIA data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for CAGT trials.

The Medical Strategy Lead will provide senior clinical and scientific expertise to all IQVIA divisions as requested and will collaborate closely with indication-specific teams to develop integrated strategies for CAGT clinical trials and studies. The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CAGT development.

As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.

RESPONSIBILITIES:

• Accountable and responsible for creating innovative, evidence-based, and patient-centered delivery strategies and solutions for CAGT trials or studies, addressing the specific needs and challenges of each customer.

• In partnership with Indication-Specific Medical Strategy, Operations, Sales, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Responsible for the inclusion of CAGT elements into proposals.

• Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.

• Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys CAGT strategy. Attends and presents at customer meeting, or bid defense or partnership meetings, as required.

• Participates in strategic business development activities including presentations to prospective clients and professional meetings.

• Maintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the CAGT landscape

• Leads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities

REQUIREMENTS:

Scientific and Research Qualifications and Experience

• A physician with experience in Cell and Gene Therapy. A degree from an accredited and internationally recognized school is required

• 5+ years clinical research relevant experience, including hands on operational delivery and/or drug development experience

• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CAGT

• Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering

• Strong clinical research skills and commitment to evidence-based and patient-centered clinical development

Professional Skills

• Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken)

• Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization

• Innovative and strategic thinker

• Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments

• Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required

• Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.

• Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results

Interpersonal Skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Maintains a positive outlook at work; handles criticism well and learns from it

• Ability to establish and maintain effective working relationships with a wide network of individuals e.g. coworkers, managers and customers

• Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Senior or Principal Statistical Programmer

Why DSSS?

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you a unique opportunity to work within an eco-system where your role is both challenging and rewarding, while working alongside colleagues who are passionate about influencing the future of medicine and advancing therapies. With IQVIA's DSSS business unit, you are not just another cog in the machine; you become a core part of a dynamic team dedicated to reshaping the future of healthcare.

Additional Benefits:

• Home-based remote work opportunities
• Great work/life balance
• Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors 
• Cohesive team environment fostering a collaborative approach to study work
• Variety of therapeutic areas, indications and, study phases
• Job stability; long-term engagements and development opportunities
• Technical training and tailored development curriculum
• Career advancement opportunities

Job Requirements:

• Generates SDTM domains, ADaM datasets, and Define.xml files with proficiency in creating specification files for these domains.
• Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data.
• Reviews output across programs to ensure consistency.
• Reviews maintains and approves study documents per standard procedures.
• Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures.
• Provides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reporting.
• Participates in the development and/or maintenance of departmental procedures and standards.
• Performs programming using techniques such as macro language, advanced data manipulation, and statistical procedures.
• Implements data management plans designed to meet project and protocol deadlines.
• Education/Experience:  Minimum bachelor’s degree in Statistics, Computer Sciences, Bioinformatics, or related field PLUS  8+ years of clinical trials industry experience.

This position is Full-Time and remote based anywhere in the United Sates or Canada

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Your opportunity

IQVIA, a leading Human Data Science company, is seeking a dynamic and experienced Senior Director of Compliance to join our Ethics and Compliance Office (ECO). In this critical leadership role, you will shape and maintain an effective healthcare compliance program on a global scale. Your responsibilities will span a wide range of duties, ensuring adherence to ethical standards and regulatory requirements.

You will interact regularly with various internal stakeholders, including Legal, Finance, Human Resources, Internal Audit, Global Quality Assurance, Chief Information Office, and all global and regional business units, as well as with external parties such as auditors, law firms, and regulators. 

As a leader, you will be a trusted member of the ECO Leadership Team, managing at least one employee and reporting to the Chief Compliance Officer, and driving a culture of ethics and integrity in all we do.

Your key responsibilities will include:

Strategic Leadership:

• Oversee IQVIA’s Code of Conduct and ethics and compliance policies.

• Manage the Ethics Line, including the Ethics Line mailbox, in accordance with applicable laws and best practices.

• Prepare materials for presentations to IQVIA’s senior leadership, Audit Committee, and external auditors.

• Provide expert guidance to internal stakeholders across Legal, Finance, Human Resources, and other departments.

• Conduct sensitive investigations as needed.

Collaboration and Stakeholder Management:

• Interact regularly with internal teams, including Legal, Finance, Internal Audit, and Global Quality Assurance.

• Build collaborative relationships with external parties such as auditors, law firms, and regulators.

People Leadership:

• Manage at least one employee.

• Report directly to the Chief Compliance Officer.

• Drive a culture of ethics and integrity throughout the organization.

To be successful on this role, you will have qualifications such as:

• Subject Matter Expertise:

  • Stay informed about global laws, regulations, and codes of ethics.

  • Provide guidance to leadership, management, and employees.

  • JD preferred, or Masters’ degree in legal relevant area, and at least 10 years of relevant experience.

  • Sound knowledge and understanding of the legal and regulatory environment in which the company operates; life sciences or healthcare compliance expertise.

• Ethics Line Management:

  • Experience managing an ethics reporting line, maintaining data and analytics, and preparing accurate, compelling presentations for a wide range of audiences including executive leadership, Audit Committee of Board of Directors, external auditors, and regulators in different regions and countries.

  • Ensure compliance with EU whistleblower laws and other relevant regulations.

• Risk Assessment:

  • Utilize deep subject matter knowledge to assess risks across various areas.

  • Experience managing Codes of Conduct and corporate policies.

  • Experienced investigator; able to guide investigations and enhance capabilities for various resources who do not regularly conduct investigations.

  • Excellent analytical and problem-solving skills; ability to synthesize and summarize complex issues.

  • Excellent judgment and discretion, including the ability to handle sensitive and/or confidential information.

You will differentiate yourself if you have:

• Relevant compliance or professional certification: Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE).

• Life sciences outsourcing experience (e.g., CRO).

Location

• IQVIA currently offers remote work arrangements.

• The incumbent must be based anywhere on the East Coast of the United States.

How to Apply

If you are a seasoned compliance professional with a passion for ethics and integrity, we invite you to be part of our mission to advance healthcare through data science. Apply now by visiting our careers page and searching for Job ID R1393190.

We look forward to welcoming a dedicated leader to our team! 🌟

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. 
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Overview

This position leads, directs and coordinates activities of a major set of key accounts within the sales organization in a large region to achieve financial and strategic growth goals across multiple accounts. The role further:

• Directs the activities of a matrixed sales teams within a large account(s) to achieve/exceed the assigned revenue and growth goals.

• Provides leadership to the sales management team to expand scope of existing contracts and identify new business opportunities.

• Develops relationships with key executives and decision makers within large and strategic accounts.

• Collaborates with all business units within R&DS (Research and Development Solutions), RWS, consulting, and client services in developing strategies to promote the full IQVIA offerings to anticipate and meet client needs.

• Provides direction to the sales management team in developing and executing comprehensive account plan(s) and monitors progress against plans.

• Works to develop associated sales and GNB goals to matrixed sales teams.

• Takes a proactive role in account and FSP (Functional Service Provider) strategy.

• Proactively works within global and regional account/sales management in the pursuit of multi-country and FSP and full-service opportunities.

Qualifications

• Bachelor’s degree in business management Req

• 15 years relevant industry experience (CRO/Pharmaceutical) Req Or

• Equivalent combination of education, training, and experience Req

• Proven track record at developing mid-level and high-level contacts.

• Solid understanding of commercialization and the principles of drug discovery and development.

• Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel

• Excellent oral and written communication skills.

• Strategic business awareness and analytical skills.

• Adaptability and flexibility to changing priorities.

• Demonstrated ability to work creatively and effectively in a fast-paced environment.

• Attention to detail and ability to work simultaneously on multiple priorities.

• Ability to maintain demanding timelines.

• Ability to influence others both internally and externally.

• Ability to work independently and as a team player.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

#DB-LI1

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Overview:

As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments. Provide written and verbal feedback to junior staff, and to customers when appropriate. Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Responsibilities:

• Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.

• Contributes to project plan concerning timelines as well as organization and table layout for a specific document.

• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.

• Review and edit documents for consistency, progression, structure, and grammar.

• Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable.

• Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.

• Participate in team and client meetings as requested. Deliverables above plus able to work independently on a range of complex clinical documents

• Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently

• Resolves complex problems independently

Education and Experience required:

• 8+ years of experience in medical writing or related field

• Required - Bachelors Degree in Life Sciences or related field

• Preferred - Masters or PhD in Life Sciences or related field

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Location: Homebased anywhere in the US

Purpose: 

Experienced R programmers needed to provide technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. 

Job Details: 

• Position: – Principal Statistical Programmer 
• Home Based 
• Min 4+ years of CRO/Pharma Industry 
• Therapeutic Areas: Oncology // Immunology // IDV // EDCP 

Key Skills:

• Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros. 
• Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. 
• Must have excellent knowledge of CDISC standards (SDTM and ADaM) 
• Thorough understanding of relational database components and theory. 
• Excellent application development skills. 
• Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. 
• Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes. 
• Minimum of 4+ years of experience in Statistical Programming in pharmaceutical or medical devices industry 
• Good verbal and written communication skills. 
• Ability to work on multiple projects, plan, organize and prioritize activities. 

Required Knowledge, Skills and Abilities: 

• Experience as technical team lead directly engaging clients and coordinating tasks within a programming team 
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines  
• Knowledge of statistics, programming and/or clinical drug development process 
• Advanced knowledge of R programming
• Base SAS, SAS/STAT, SAS Graph and SAS Macro Language 
• Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards. 
• Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL. 
• Good organizational, interpersonal, leadership and communication skills 
• Ability to independently manage multiple tasks and projects 
• Ability to delegate work to other members of the SP team 
• Excellent accuracy and attention to detail 
• Ability to delegate work to other members of the SP team [SPM] 
• Exhibits routine and occasionally complex problem-solving skills 
• Ability to lead teams and projects and capable of managing at a group level 
• Recognizes when negotiating skills are needed and seeks assistance. 
• Ability to establish and maintain effective working relationships with co-workers, managers and clients. 

Responsibilities: 

• Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files  for internal and external clients and (iii) the programming  quality control checks for the source data and report the data issues periodically.. 
• Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. 
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies. 
• Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies. 
• Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. 
• Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables. 
• Use and promote the use of established standards, SOP and best practices. 
• Provide training and mentoring to SP team members and Statistical Programming department staff. 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE: 

• Bachelor's degree from reputable university preferably in science/ mathematics related fields 

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Purpose

Responsible, with per needed-bases oversight from the Study Director-community Lead, for the execution and delivery of the GCO supported clinical studies of standard to medium complexity and priority per the Operational Execution Plan (OEP) and clinical study protocol. The Senior Study Leader is the leader of the cross-functional clinical trial team, guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team, Global Clinical Team and GCO objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CRR. Oversee budget and people allocation within assigned study/studies. Contribute in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjust quickly to changing conditions and business needs.

Accountabilities

Leader of the Clinical Trial team

• Leads the clinical trial team with per needed-basis oversight from the Study Director-community Lead and support from the Clinical Operations Program Head, delivery of multiple medium to complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and a team of teams’ model
• Acts as the CTT product owner with duties and responsibilities per established ways of working
• Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Execution Plan and clinical study protocol
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies to achieve long-term business impact
• In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
• Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders
• Proactive risk management and inspection readiness
• Responsible for developing clinical study timelines with per needed-basis oversight from the Study Director-community Lead and support from the Clinical Operations Program Head, and overseeing assigned study budgets
• Ensures systems are maintained with up-to-date study status, risks and issues
• Fosters a close working relationship with SSO Clinical Project Managers to strengthen the relationship between the global and local teams
• Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Project Managers
• Fosters a close working relationship with the Vendor Program Managers to strengthen the relationship between the vendors and CTT to deliver on clinical study objectives
• Fosters a close working relationship with the CDO Trial Data Scientist to deliver on clinical study objectives
• Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation
• Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results and the internal/external publications, when appropriate
• May deputize for the Clinical Operations Program Head as a leader and spokesperson for the CTT at sponsor internal meetings
• Play a key role in achieving excellence in study operations and management through process improvement in collaboration with Study Leadership Community Lead/Host and GCO Process, Training and Compliance
• External budget accountability for multiple clinical studies

CTT Coaching and Resource Management

• Partners and collaborates with functional line leadership to ensure optimal people staffing of the study team
• Build high-performing teams and create an empowered, psychologically safe culture to foster high performance in a matrix environment
• Services as the single point of contact as the SSO representative in the CTT for internal/external customers

Community Participation

• Active member of a community as a citizen within the study leadership organization
• Apply and encourage new CTT mindset, values, and principles; be a catalyst for these CTT ways of working, including agile

Activities

• Facilities CTT collaboration across the CTT to include sub-teams through agile events, meetings and workshops
• Participates and reports study progress and issues/resolution plan at the GCO sub-teams and Global Clinical Team
• Engaged and active participant in assigned Study Leadership Community

Leadership Capabilities

• Demonstrated ability in building relationship and communication skills with experience leading diverse work teams, achieving study excellence, and engaging functional partners coupled with excellent problem-solving, negotiation, and conflict resolution skills
• Transformational and servant leadership capabilities with ability to role model agile leadership
• Proven strategic capabilities; organizational awareness; advanced planning and project management skills as well as understanding of business processes
• Establishment of successful external partnerships and collaborations
• Proven ability to coach and motivate others

Education

• Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.

Experience

• 4+ years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I-IV of standard to high complexity and priority
• 3+ years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (planning, executing, reporting and publishing) in a global matrix environment in pharmaceutical industry or a CRO, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and sponsor standards
• Experience in managing people globally in a complex matrix environment preferred
• Management of virtual teams. Proven ability and strong experience leading teams and building capabilities
• Experience in developing effective working relationships with internal and external stakeholders
• Excellent communicator and presenter; ability to communicate at all levels
• Excellent organization and prioritization
• Strong negotiation and conflict resolution skills and enterprise mindset
• Strong project management skills and demonstrated ability to meet timelines
• Proven track record in trial operations process improvement(s) in some aspects of clinical trials
• Superior strategic thinking with strong analytical and problem-solving skills
• Knowledge of appropriate therapeutic area strongly preferred  

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Work with one of our preferred clients! Our client is a leading pharmaceutical/biotech company dedicated to advancing medical science and improving patient outcomes through the development of innovative therapeutics. Their research-driven organization focuses on discovering, developing, and commercializing novel drugs across various therapeutic areas. We are seeking a highly skilled and motivated Principal Statistical Programmer with expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to join our dynamic FSP team.

Position Overview: As a Principal Statistical Programmer with a specialized focus on PK/PD, you will play a pivotal role in the design, execution, and analysis of clinical trials to support the development of our promising drug candidates. Leveraging your extensive knowledge of statistical programming and PK/PD principles, you will collaborate closely with cross-functional teams of scientists, clinical researchers, and biostatisticians to ensure the successful implementation of our clinical development programs.

Qualifications:

• Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry.

• Proven expertise in PK/PD data analysis and interpretation, including modeling and simulation.

• Solid understanding of clinical trial designs, protocols, and regulatory requirements related to PK/PD endpoints.

• Familiarity with industry standards such as CDISC data structures and guidelines for data submissions.

• Strong analytical, problem-solving, and communication skills, with the ability to work effectively in cross-functional teams.

• Detail-oriented with a commitment to producing high-quality deliver

• Master's or Ph.D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD) tables within tight timelines.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Location: Home-based

Job Description
Develop statistical methods sections of protocols and review case report forms (CRFs).  Prepare analysis plans and write specifications for analysis files, tables, and figures.  Communicate with clients regarding study protocol or statistical analysis issues as they arise.  Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.  Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition.  Provide training, guidance and mentorship to lower level and new staff.

Essential Functions

• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.

• Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication.  If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting.

• Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision.

• Statistical Analysis Plan (SAP) and Shells:  Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed.

• Datasets:  Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment.

• Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.

• Timelines:  Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.

• Financials:  Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions.

• Knowledge Sharing:  Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed.

• Risk Management:  Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations.

• Other  Clinical Data Interchange Standards Consortium (CDISC) requirements:  Leadership:  Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols.

• Study Start up:  Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.

• Protocol:  Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods).

• Proposals:  May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses.

• Clinical Study Report (CSR):  Reviews or drafts CSR or statistical report.

• Customer:  On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.

• Lock and Unblinding Process:  Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician.

Qualifications

• Bachelor's Degree Biostatistics or related field and 3 - 5 years relevant experience Req Or Master's Degree Biostatistics or related field and 3-5 years relevant experience Req Or Ph.D. Biostatistics or related field and 1 year relevant experience Req

• Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience.

• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

• Excellent written and oral communication skills including grammatical/technical writing skills.

• Excellent attention and accuracy with details.

• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Familiarity with moderately complex statistical methods that apply to applicable clinical trials.

• Strong individual initiative.

• Strong organizing skills.

• Strong working knowledge of SAS computing package.

• Familiarity with other relevant statistical computing packages such as nQuery.

• Strong commitment to quality.

• Ability to effectively manage multiple tasks and projects.

• Ability to lead and co-ordinate small teams.

• Ability to solve moderately complex problems.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

• Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status