Associate Director, Biostatistics
Core
Designs clinical trials and statistical analysis plans for rare genetic disease therapies, writing protocol statistical sections and contributing to regulatory documents and scientific articles.
Role type
Senior IC biostatistician (clinical development)
Builds
Clinical trial protocols, statistical analysis plans, clinical study reports, and regulatory submissions for Alnylam's rare genetic disease pipeline.
Domain
Biopharmaceuticals / Clinical Development / Rare Genetic Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design (Phase 3), adaptive trial design, regulatory strategy (FDA/International), SAS programming, R programming, CDISC standards (SDTM, ADaM, CDASH), statistical analysis plan development, clinical study report writing.
Preferred skills
Experience with EAST software, experience with ICH GCP guidelines, experience with drug development for rare genetic diseases.
Responsibilities
Design clinical trials in collaboration with Clinical Development and Regulatory teams; write statistical sections of clinical trial protocols; prepare statistical analysis plans; collaborate on eCRF design; provide statistical guidance on ongoing trials; summarize and analyze trial data with Statistical Programmers; write ADS and ad hoc analysis specifications; contribute to clinical study reports and regulatory documents (DSURs, Briefing Documents); summarize data for scientific articles.
Seniority
Senior, hands-on IC
