Director / Senior Director, Biometrics & Data ScienceJob SummarySeismic 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.
Key Responsibilities- 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, and clean and standardize clinical and biomarker data, such as transcriptomics, proteomics, and flow cytometry, for integration and analysis.
- Perform exploratory analyses linking biomarkers to clinical outcomes.
- Partner closely with colleagues in Immunology, Biomarker & Translational Sciences, and Clinical Development, and Operations, to translate scientific and clinical questions into statistical and data deliverables.
- Build scalable biometrics practices, standards, and SOPs that support an expanding clinical pipeline without introducing unnecessary bureaucracy.
Required Qualifications- Willingness to roll up your sleeves and take a hands-on approach to cleaning and standardizing data, creating a data-driven statistical analysis plan for each project, reviewing statistical deliverables, performing and/or overseeing analyses of clinical and multi-omic biomarker data, and driving activities to completion in a lean team environment.
- MS in biostatistics, statistics, or a related quantitative discipline and 8+ years of biostatistics experience in the biotechnology or pharmaceutical industry, or 12+ years for the Senior Director level.
- Hands-on experience designing clinical studies, authoring statistical analysis plans, and conducting analyses, with proficiency in relevant programming tools (e.g., SAS, R, Python).
- Proven experience overseeing CROs for biostatistics, statistical programming, and data management, with working knowledge of EDC systems and CDISC standards.
- Working knowledge of ICH-GCP and E9 guidelines and data integrity requirements for clinical data.
- Working familiarity with high-dimensional biomarker data and their integration with clinical trial data.
- Excellent written and verbal communication skills, strong organization and documentation discipline, and the ability to work effectively across internal teams and external partners.
Preferred Experience- Experience supporting immunology, autoimmune, inflammatory, or allergic disease clinical programs.
- Experience with early-phase studies, biologics, and PK/PD data.
- Hands-on analysis of omics data, such as flow cytometry, bulk or single-cell transcriptomics.
- Experience as the first or sole statistician in a venture-backed biotechnology company or another lean environment, including management of academic collaborations.
Competencies- Ownership and accountability for outcomes, balancing hands-on contribution with effective oversight.
- Statistical rigor and integrity, with sound judgment about what data can and cannot support.
- Operational discipline, maintaining careful attention to data quality, documentation, and traceability.
- Collaborative leadership that builds trust across disciplines and with CRO and external partners.
- Patient focus, connecting data integrity and analytical decisions to participant safety and the potential impact of Seismic's medicines for patients.
OtherThis role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic's company policies and business needs.
Limited travel for collaborator, vendor, and scientific meetings, as needed.
The annual base salary range for this position is $200,000.00 - $315,000.00. Salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.
