FSP Principal Biostatistician, Safety Analytics

Job Responsibilities

• 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.
• 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 multi-disciplinary 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, etc.
• Serve 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.
• Perform exploratory safety analyses.
• Validate analysis variables and statistical outputs.
• Interpret study results and review reports of study results for accuracy.
• Present, communicate and interpret safety analyses to study teams.
• Support exploratory analyses.
• Participate in pre-IND or NDA activities.

Qualifications

• 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).
• Able 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.
• 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.