Manager, Biostatistics
Core
Lead statistical guidance and support for drug development programs, including study design, analysis plans, and regulatory submissions for cancer immunotherapies.
Role type
Manager, Biostatistics
Builds
Translational development plans, PK/PD reports, NDA/BLA submissions, and clinical trial analyses for CAR T-cell therapies.
Domain
Biopharmaceuticals / Immuno-oncology / Drug Development
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Clinical trial design, Drug development lifecycle, Regulatory principles (FDA/EMA), Statistical methodologies, Multivariable predictive modeling, Vendor management, Cross-functional collaboration, Technical reporting, SAS, R
Preferred skills
PhD in Biostatistics/Statistics, Immuno-oncology publication experience, Pharmacokinetics/pharmacodynamics knowledge, AI/agent development for analysis workflows
Technologies
SAS, R
Responsibilities
Design translational development plans and statistical analysis plans (TSAPs), Author technical reports and publications for regulatory agencies, Collaborate with scientists/clinicians on clinical trial endpoints, Advise teams on statistical and bioinformatics methodologies, Monitor project progress and oversee external vendors
Seniority
Manager, hands-on IC with team leadership