Biometrics & Data Science
Director, Biostatistics
Lead statistical strategy for a Phase 3 program in major depressive disorder. You will design the studies, own the estimands and represent statistics in FDA meetings.
A typical mandate
The company develops new treatments for mood disorders, with a lead program entering Phase 3 in major depressive disorder. Psychiatry trials carry real placebo response and missing data risk. The design choices made now will decide whether the program reads out clearly.
What the role owns
- Own statistical strategy, sample size and design for the Phase 3 program
- Define estimands and sensitivity analyses consistent with ICH E9(R1)
- Represent biostatistics in FDA meetings and data monitoring committee interactions
- Oversee CRO deliverables, including SAPs, TLFs and CDISC datasets
- Partner with clinical on endpoints, rating scales and placebo response mitigation
- Lead and grow a small team of statisticians and programmers
What great candidates bring
- PhD in biostatistics or statistics, with 10+ years in clinical development
- Phase 3 design and analysis experience, ideally in CNS or psychiatry
- Command of ICH E9(R1) estimands, missing data methods and multiplicity
- Working knowledge of CDISC SDTM and ADaM and FDA submission data standards
- Experience overseeing CRO biometrics vendors
- Proficiency in SAS and R
Why it matters
- Senior statistical voice in the company, reporting to the CMO
- Equity and annual bonus
- Direct influence on the design of a pivotal program
- Hybrid schedule
Related profiles
You may also consider.
Senior Director, Medical Affairs
Radiopharmaceutical company · Phase 3
Greater Philadelphia · Hybrid
Director, Discovery Biology, Immunology
Preclinical immunology biotech · Series A
Greater Seattle · On-site
Director, Regulatory and Clinical Affairs, Diagnostics
Molecular diagnostics company · Commercial stage
Greater San Diego · Hybrid