Senior Biostatistician FSP, Late Phase

IQVIA•Durham, NC

1d•Remote

About The Position

Data Sciences Staffing Solutions (DSSS), a unit within IQVIA, provides sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This role offers 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, providing unique opportunities to influence the future of medicine and advance therapies to market. The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.

Requirements

PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
MS in Statistics, Biostatistics, or related field with 4+ years of industry experience.
At least 3 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.
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
Experience in production programming of ADAM and TLF
Experience with CDISC, including SDTM, ADAM, CDASH
Solid understanding of multiple imputation methods

Nice To Haves

Interaction with regulators including Advisory Committee meetings.
2+ years of experience with renal therapeutic or CNS area.

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
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, etc.

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.
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.