FSP Principal Biostatistician, Safety Analytics

Job Title

FSP Principal Biostatistician, Safety Analytics

Home-based in the U.S. or Canada

Data Sciences Staffing Solutions (DSSS) is a unit within IQVIA that provides sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all 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 offering unique opportunities to influence the future of medicine and advance therapies to market.

The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2, and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes.

• Home‑based remote working opportunities.
• Work/life balance and flexible schedules.
• Collaboration with motivated, high‑performance statistical and research teams.
• Technical training and a tailored development curriculum.
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long‑term engagements and redeployment 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.

• Support Safety Analytics with ADaM/TFL standard development for hypersensitivity, injection/infusion site reaction or other safety deliverables.
• Support Safety Analytics and the study team on the delivery of patient profile display for hepatic or other areas.
• Provide ADaM/TFL/interactive package review support for the Safety Analytics team’s portfolio deliveries, including cross‑checks between interactive outputs and TFLs.
• Interrogate root causes of issues identified during ADaM/TFL/interactive package review.
• Provide statistical leadership and support for safety analyses for Phase 1/2/3 trials.
• Collaborate with multidisciplinary project teams to establish project objectives and timelines.
• Participate in study design discussions, including protocol development.
• Write the statistical sections of clinical trial protocols.
• Review CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed.
• Develop and review statistical analysis plans and TFL templates.
• Monitor internal and CRO project activities, including timelines, deliverables, and resource availability.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Contribute to clinical study reports and regulatory documents (e.g., NDA, DSURs, briefing documents, ISS, ISE).
• Serve as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
• Guide and supervise programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
• Perform validation of analysis variables and statistical outputs.
• Interpret study results and review study reports for accuracy.
• Present, communicate, and interpret safety analyses to study teams.
• Support exploratory analyses.
• Participate in pre‑IND or NDA activities.

• PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• At least 2 years of Phase 1, 2, and 3 clinical trial experience.
• Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
• Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
• Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root causes and errors.
• Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
• R/SAS programming skills.
• Demonstrated ability to work pro‑actively and independently.
• Able to effectively communicate ideas and to…