FSP Principal Biostatistician, Safety Analytics

FSP Principal Biostatistician, Safety Analytics

Location:

Home-based in the U.S. or Canada

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 high-performance statistical and research teams
• Technical training and tailored development curriculum
• Research opportunities matched to skillset
• Promising career trajectory and long-term engagements
• Focus on bringing new therapies to market rather than project budgets
• Experience with regulatory submissions in an engaging, fast-paced environment

• Support safety analytics with ADaM/TFL standard development of safety deliverables, including specialty areas such as hypersensitivity and injection/infusion site reaction.
• Support safety analytics and study team on delivery of patient profile display for hepatic or other areas.
• Provide ADaM/TFL/interactive package review support, including cross-checks between interactive outputs and TFLs.
• Interrogate root cause 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 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.
• 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 exploratory safety analyses.
• Validate analysis variables and statistical outputs.
• Interpret study results and review reports for accuracy.
• Present, communicate and interpret safety analyses to study teams.
• 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 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.
• Ability to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
• Strong communication and time‑management skills; 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.
• Effective communication of ideas and constructive program management.
• Understanding of ICH GCP, ICH E9, and general knowledge of industry practices and standards.
• Experience with CDISC SDTM and CDASH.

• Leading DSBM or DMC for biostatistics.

IQVIA is proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

Potential base pay range: $ – $ (annualized). Actual base pay offered may vary by factors such as qualifications, location, and schedule.