Principal Biostatistician FSP, Late Phase

IQVIA • Durham, NC

12d • Remote

About The Position

The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.

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 pro-actively and independently.
• 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

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

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Author statistical analysis plans.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in pre-IND or NDA activities.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

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.

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