Company: Fulcrum Therapeutics, Inc.
Posted on: June 6, 2021
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
- 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
- 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
- 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
- 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
- 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
- Intermediate to advanced proficiency in statistical programming
using SAS and other statistical software (e.g. R, Python,
- 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.
- Good presentation skills.
- Strong collaborative skills and ability to work with a
- Ability to present to management and other groups to clearly
communicate statistical thinking and ideas.
- Ability to work independently with minimal supervision.
- 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.
Keywords: Fulcrum Therapeutics, Inc., Cambridge , Senior/Principal Biostatistician, Other , Cambridge, Massachusetts
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