Principal Biostatistician FSP, Late Phase
About The Position
Data Sciences Staffing Solutions (DSSS), a unit within IQVIA, provides fully embedded resources to sponsors through a Functional Service Provider (FSP) partnership. This allows employees to work for an industry-leading global CRO while collaborating directly with cross-functional sponsor teams from world-class pharmaceutical and biotech companies. The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients, focusing on late-phase studies. IQVIA aims to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.
Requirements
- PhD in Statistics, Biostatistics, or related field with 5+ years of 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 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
- Production 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, etc.
Benefits
- Home-based remote working opportunities
- Work/life balance
- 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
- Incentive plans
- Bonuses
- Other forms of compensation
- Range of health and welfare and/or other benefits
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
