We are seeking an experienced Biostatistician to join the team and lead the statistical strategy within the Clinical Development function. This individual would report to the Head of Clinical Development and would be responsible for the biostatistical data management function. Additionally, they will provide statistical input and support to ensure plans and analyses are accurately designed, specified and conducted; and will ensure achievement of statistical deliverables with efficiency and quality.
- Serve as biostatistics leader at Fulcrum and provide internal training to the team as needed.
- Provide statistical oversight of all research study protocols in the preclinical and clinical space and participate in reviews as needed.
- Ensure consistency in statistical methods applied to all study designs.
- Provide detailed review of existing data to inform assumptions for design of clinical trials and to set appropriate assumptions for power calculations.
- Provide sample size and design proposals for Clinical Trials.
- Biostatistics project management including but not limited to vendor hiring, vendor management, directing statistical programming, and escalating issues in a timely manner.
- Be responsible for oversight of data management in outsourced clinical trials.
- Function as study level statistician for internal studies.
- Ensure high quality, timely delivery of statistical analysis plans and study tables/listings and statistical reports.
- Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications.
- Provide support for publications as needed.
- Support interactions with Regulatory Agencies on statistical issues and provide solutions as needed.
- Author or review statistical SOPs, data management SOPs, and Working Instructions.
- Keep up-to-date with the latest statistical methods development related to clinical trials and attend statistical workshops or seminars.
- PH.D. or master’s degree in Biostatistics or applied mathematics.
- Minimum of 10+ years of industry experience as a Biostatistician in clinical trial.
- Minimum of 6 years of SAS programming experience
- Minimum of 3 years of documented regulatory submission support experience (one or more of SAP, submission dossier review, briefing package review, responses to inquiries)
- Proficiency in statistical programming using SAS and other statistical software
- Experience in providing vendor oversight
- Ability to present to management and other groups to clearly communicate statistical thinking and ideas
- Regulatory interaction experience preferred (pre-NDA, End-of-Phase 2, SPA, Adcom, Audit)