FSP Principal Biostatistician, Study Powering and Design

IQVIA•Durham, NC

5d•Remote

About The Position

The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. This role is part of Data Sciences Staffing Solutions (DSSS), a unit within IQVIA that provides fully embedded resources through a Functional Service Provider (FSP) partnership. This allows for the benefits of working for an industry-leading global CRO while collaborating directly with cross-functional sponsor teams at world-class pharmaceutical and biotech companies.

Requirements

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.
At least 3 years of experience in supporting simulations, sample size and power calculations.
Demonstrated ability to work pro-actively and independently.
Able to effectively communicate statistical ideas and collaborate with cross-functional teams.
Ability to efficiently use R or SAS to perform analyses.
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.

Nice To Haves

Supporting written communications with regulators.
1+ years of experience with immunology therapeutic area.
Bayesian methods.

Responsibilities

Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
Perform samples size and power calculations for optimizing study design.
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).

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.