Director of Biometrics & Data Science — Clinical Biomarker Lead

Automatic Data Processing, Inc.; Cambridge (MA); Sur place; USD 200 000 - 315 000; Plein temps

Résumé du poste

Seismic Therapeutic in Watertown, MA seeks a biometrics and data science lead to perform and oversee biostatistics for our clinical programs, combining hands-on statistical analysis with oversight of data management and CRO activities.

You will steward clinical and complex biomarker data, ensuring organization, standardization, and linkage to biospecimens and collaborations, partnering with Immunology, Translational Sciences, and Clinical Development.

Qualifications

• Hands-on data cleaning and standardization and building a data-driven SAP for each project.
• Experience designing clinical studies and writing SAPs with SAS, R, or Python.
• Oversight of CROs for statistics, programming, and data management.
• Familiarity with ICH-GCP, E9, and data integrity in clinical data.

Responsabilités

• Conduct hands-on biostatistics for clinical studies and oversee CRO activities.
• Oversee CRO data management from database build to lock.
• Oversee CRO programming and review SDTM/ADaM outputs.
• Organize and standardize clinical and biomarker data across studies.
• Coordinate data transfers from labs and biomarker vendors.
• Perform exploratory analyses linking biomarkers to outcomes.
• Collaborate with Immunology, Translational Sciences, Clinical Operations, and Regulatory.
• Build scalable biometrics standards and SOPs.

Connaissances

Biostatistics

Data analysis

CRO oversight

Statistical programming

Clinical study design

Formation

MS in biostatistics

Outils

SAS

R

Python

CDISC

Description du poste

Seismic Therapeutic in Watertown, MA seeks a biometrics and data science lead to perform and oversee biostatistics for our clinical programs, combining hands-on statistical analysis with oversight of data management and CRO activities.

You will steward clinical and complex biomarker data, ensuring organization, standardization, and linkage to biospecimens and collaborations, partnering with Immunology, Translational Sciences, and Clinical Development.