Principal Biostatistician FSP, Late Phase
ROLE DEFINITION & RESPONSIBILITIES
Job Level: FSP Principal Biostatistician, Late Phase
Location: Home-based in the U.S. or Canada
Why DSSS?
Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.
Job Summary
The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.
Additional Benefits
Home-based remote working opportunities.
Work/life balance as well as flexible schedules.
Collaborating with motivated, high-performance, statistical and research teams.
Technical training and tailored development curriculum.
Research opportunities that match your unique skillset.
Promising career trajectory.
Job stability: long-term engagements and re-deployment opportunities.
Focus on bringing new therapies to market rather than project budgets and change orders.
Experience with regulatory submissions.
Engaging, fast-paced environment.
Good work-life balance.
Job Responsibilities
Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
Author statistical analysis plans.
Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
Author or review analysis dataset and TLF specifications
Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF)
Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
Interpret study results and review reports of study results for accuracy.
Support exploratory analyses.
Participate in IND or NDA activities.
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).
Qualifications
PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
At least 2 years in Phase 2/3 clinical trial experience.
Demonstrated ability to work pro-actively and independently.
Able to effectively communicate ideas and collaborate with cross-functional teams
Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
Support of various regulatory submissions
Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
Experience in validation/programming of ADAM and TLF
Experience with CDISC, including SDTM, ADAM, CDASH
Solid understanding of estimands and multiple imputation methods.
Desired Experience
Supporting written communications with regulators.
1+ years of experience with immunology therapeutic area.
Bayesian methods
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $115,900.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
IQVIA is a leading global provider of advanced analytics, technology solutions, and contract research services (CRO) to the life sciences industry. The company helps pharmaceutical, biotech, and medical device clients accelerate the development and commercialization of new medical treatments through its extensive data, technology, and human expertise. Their offerings span from clinical trial design and execution to real-world evidence and commercial effectiveness.
EXPECTED CAREER ROADMAP
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