Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.
The Senior Biostatistician will be responsible for the biostatistical support for several assigned clinical studies. The ideal candidate will provide statistical input and support to ensure statistical plans and analyses are appropriately designed, specified, and conducted; and will ensure achievement of statistical deliverables with efficiency and quality. This is an opportunity to interact cross-functionally across Fulcrum Therapeutics as well as working externally with vendors.
- Provide statistical oversight of assigned research study protocols in the preclinical and clinical space.
- Ensure appropriate statistical methods applied to all study designs.
- Provide detailed review of existing data to inform assumptions for design of clinical trials.
- Support the development of statistical analysis plans and statistical analysis to meet project objectives.
- Represent the statistical function at cross-functional team meetings as needed.
- Participate in study protocol reviews as needed.
- Be responsible for oversight and communication with external vendors for statistics and programming issues in outsourced clinical trials.
- Biostatistics project management including but not limited to vendor hiring, vendor management, directing statistical programming, and escalating issues in a timely manner.
- Function as study level statistician for internal studies.
- Ensure high quality, timely delivery of statistical analysis plans and study tables, listings and figures.
- Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being performed 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.
- Attend statistical workshops or seminars.
- Give statistical presentations for internal training at the company.
- PhD in statistics or biostatistics with at least 2 years of relevant experience, or MS in statistics or biostatistics with at least 5 years of relevant experience required.
- Excellent knowledge of statistical methodology and applications.
- Intermediate to advanced proficiency in statistical programming using SAS and other statistical software (e.g. R, Python, etc.).
- Good presentation skills.
- Strong collaborative skills and ability to work with a cross-functional team.
- Ability to present to management and other groups to clearly communicate statistical thinking and ideas.
- Ability to work independently with minimal supervision.
- Principal Biostatistician candidates will possess the following:
- Experience with relevant FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials or observational research, and regulatory submissions.
- Experience in providing vendor oversight.
- Experience working on Phase 1 and Phase 2 clinical trials. Experience working on pivotal Phase 3 trials is a plus.
- Experience working on adaptive or other innovative clinical study designs is a plus.