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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # FSP Principal Biostatistician, Safety Analytics - **Company:** IQVIA - **Location:** Durham, NC, United States (Remote available) - **Experience:** Experienced - **Salary:** $111,000.0 - $309,000.0 - **Contract:** Permanent contract - **Skills:** Data Analysis, Coherent Remote File System (CRFS), SAS (Software), Data Management, Spotfire - **Published:** July 16, 2026 - **Apply:** https://www.juju.com/job/00000000ggv7kh ## About the Role + 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 cause 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 his/her ideas and to manage programmers in a constructive manner. + Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. + Experience with CDISC SDTM and CDASH Desired Experience: + Leading DSBM or DMC for biostatistics ## Description 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., + Support Safety Analytics with ADaM/TFL standard development of safety deliverables, including specialty areas such as Hypersensitivity, Injection/Infusion Site Reaction. + 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 supported portfolio deliveries, including cross-checks between interactive outputs and TFLs. + Interrogating root cause of issues identified during ADaM/TFL/Interactive package review + Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials. + Collaborate with multi-disciplinary project teams to establish project objectives and timelines. + Participating in study design discussions, including protocol development + Write the statistical sections of clinical trial protocols. + Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed. + Developing and reviewing 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, etc. + Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements. + Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures. ## Related Videos - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Beyond Gut Feelings: The Rise of Data-Driven HR](https://www.wearedevelopers.com/videos/1326-beyond-gut-feelings-the-rise-of-data-driven-hr) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) - [Kettle and Pot or Peas in a Pod? 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