Director of Data and Biostatistics

Job title: Director of Data and Biostatistics

Location: Massachusetts

The Director of Data and Biostatistics will lead all data and statistical functions within Clinical Affairs for medical device studies. This role oversees clinical data systems, ensures data accuracy and regulatory compliance, and directs statistical analysis to support safety, efficacy, and research objectives.

Key Responsibilities:

Lead data management strategy for medical device clinical trials.

Support study design and interpretation of clinical data.

Develop and oversee statistical analysis plans.

Direct setup and validation of EDC and clinical databases per protocols and regulations.

Partner with Clinical Operations, Medical Affairs, Regulatory, and Quality.

Ensure strong processes for data collection, cleaning, and reporting.

Manage CROs and data/biostatistics vendors.

Maintain SOPs and best practices for data and statistical activities

Lead and mentor data management and biostatistics staff.

Education & Experience:

Master s in Life Sciences, Health Informatics, Biostatistics, or related field.

8 10 years of data management/biostatistics experience, including 3+ years in leadership.

Strong experience in medical device trials and knowledge of FDA/ISO requirements (21 CFR Part 11, ISO 14155).

Proficient with clinical data systems (Rave, InForm, REDCap) and CDISC standards.

Strong statistical, communication, and project management skills.

Skills:

Excellent written and verbal communication.

Strong cross-functional collaboration.

Proficient in database and documentation tools.

Organized, adaptable, and detail-oriented.

Strong record-keeping skills.