Company Overview
Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is Pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).
Description
Reporting to VP of Biometrics, the Director of biostatistics within the Biometrics Department is a hands-on role and is expected to be the statistics subject matter expert for clinical development programs and studies, including oversight of statistical activities in outsourced clinical trials, while ensuring adherence to all regulatory requirements. This individual is expected to have an in-depth understanding of innovative study designs and statistical methodologies, including estimand strategies, endpoint selection, missing data and multiplicity handling. In addition, this individual will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics department and with clinical development, clinical operations, pharmacovigilance, medical writing, and regulatory affairs.
Responsibilities
- Function as a lead statistician for internal studies.
- Contribute to enterprise strategy through proactive cross-functional collaborations and influence through decision making.
- Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address statistical questions from regulatory agencies.
- Conduct ad-hoc analyses as needed.
- Provide oversight of biostatistics activities in outsourced clinical trials.
- Ensure high quality, timely delivery of statistical analysis plans and statistical outputs.
- Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications.
- Provide support for publications as needed.
- Author or review statistical SOPs and Working Instructions.
Qualifications
- A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 8 years of relevant clinical biostatistics experience in pharma, biotech or CRO industry -OR- a Master's degree and a minimum of 10 years of relevant industry experience is required.
- Comprehensive knowledge of innovative study design and statistical methodologies.
- Extensive knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.).
- Regulatory interaction and submission experience is highly preferred.
- Experience in oversight of biostatistics activities in outsourced clinical trials is highly preferred.
- Proficiency in statistical software (e.g., SAS, R) and simulation.
- Excellent verbal and written communication skills.
- Ability to work collaboratively in a multidisciplinary team environment.
