Topic: regulatory submissions

Provide study-level statistical leadership for clinical trials across Beam’s development programmes. The role contributes to protocol design, analysis plans, randomisation, data collection and interpretation of trial outcomes. It also reviews biometrics work from external research organisations and supports clinical reports, regulatory submissions and scientific publications. The position is based in Cambridge, Massachusetts.

A 16-month statistical programming contract supporting clinical studies and regulatory submissions. The programmer develops and validates SAS analyses, creates CDISC datasets and prepares tables, figures and listings. The role collaborates with biostatistics, data management and clinical operations. Based in South Boston, Massachusetts, the employer describes a working arrangement with at least three onsite days per week.

Direct clinical development of zugocaptagene-geleucel for autoimmune disease. Responsibilities include early- and late-stage trial strategy, protocol design, medical monitoring, interpretation of safety and efficacy data, and mentoring clinical development leads. The director also contributes to regulatory submissions and scientific presentations. Based in South Boston, Massachusetts, the employer describes at least three onsite days per week.