FSP Principal Biostatistician, Medical Affairs

IQVIA•Durham, NC

21h•$111,000 - $309,000•Remote

About The Position

The Principal Biostatistician is responsible for providing statistical analysis support for pharmaceutical research in Phase 2 and 3 clinical trials. 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 offers the benefits of working for a global CRO and collaborating directly with cross-functional sponsor teams at world-class pharmaceutical and biotech companies.

Requirements

PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
At least 3 years in Phase 2/3 clinical trial experience.
Demonstrated ability to work proactively and independently in a fast-paced environment.
Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
Experience with CDISC, including SDTM, ADAM, CDASH.

Nice To Haves

Contributing to peer-reviewed publications and presentations.

Responsibilities

Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
Author statistical analysis plans.
Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations to provide statistical expertise.
Contribute to publications and presentations.
Provide guidance and supervision to programmers in planning and execution of analysis.
Independently program or validate statistical outputs (tables, listings and figures) using SAS or R.
Interpret study results and review reports of study results for accuracy.
Support exploratory analyses.

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.