Director​/Senior Director, Biometrics & Data Science

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R&D GENERAL Full Time Employee Professional Cambridge, MA, US

2 days ago Requisition

Salary Range: $ To $ Annually

Seismic Therapeutic is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub.

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At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for a highly motivated, hands‑on biostatistician and data scientist to build and lead the biometrics function and join our small, dynamic and high‑performing Clinical Development team.

Seismic is seeking a biometrics and data science lead to join our growing Clinical and Development team. You will perform and oversee biostatistics for our clinical programs, combining hands‑on statistical expertise with oversight of data management and statistical programming performed by CROs, following Seismic's externalized operating model.

You will also serve as the steward of Seismic's clinical and complex biomarker data, ensuring that data are organized, standardized, and linked to available biospecimens and external collaborations. As an integral member of the Clinical Development team, you will partner closely with colleagues in Immunology, Translational Sciences, Clinical Operations, and Regulatory.

This position may be filled at the Director or Senior Director level, depending on experience, technical leadership, and scope of prior responsibilities. Senior Director candidates should demonstrate broader ownership of biometrics strategy across programs, including vendor strategy and budgets, health authority interactions, and readiness to build and lead a team.

• Conduct hands‑on biostatistics for Seismic's clinical studies, including study design input, sample size calculations, authoring/reviewing statistical analysis plans, and performing and interpreting analyses. Provide statistical input to protocols, clinical study reports, regulatory submissions, and safety review committees, and oversee any biostatistics activities delegated to CROs.
• Oversee CRO data management from database build through lock, including eCRF and EDC design review, data management plans, edit checks, ongoing data review and reconciliation, and database lock readiness.
• Oversee CRO statistical programming, including SDTM and ADaM datasets and tables, listings, and figures, and independently review and validate key outputs. Select CRO biometrics partners and manage their scope, timelines, and performance.
• Organize clinical and biomarker data for each study and project in a compliant way and keep them current as new data arrive, including logs of issues that arise, how they are resolved, and which decisions are made.
• Coordinate data transfers from laboratories and biomarker vendors,…