Clinical Director of Data and Biostatistics in Acton, MA - Locals Required
Company: GD Resources
Location: Acton
Posted on: February 14, 2026
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Job Description:
Job Description Job Description Job Title: Clinical Director of
Data and Biostatistics Job Location: Manchester, NH Job Location:
12 Months Rate: $130/hr on W2 Must be local to Acton, MA and
available for onsite meetings Description: The Director of Data and
Biostatistics will lead data operations for our Clinical Affairs
team focused on medical devices. This role will be responsible for
overseeing the design, implementation, and maintenance of clinical
data systems, ensuring data integrity, and supporting regulatory
compliance across all clinical studies. In addition, this role will
be responsible for overseeing the statistical analysis of clinical
study data ensuring appropriate statistical methods and accurate
analyses to evaluate efficacy and safety and answer research
related questions. Responsibilities: Lead the development and
execution of data management strategies for clinical trials
involving medical devices. Support the design of clinical studies
and ensure accurate interpretation of clinical study data working
cross functionally to ensure the needs of the business are met.
Lead the development and execution of statistical analysis plans
for clinical studies. Oversee the design and validation of clinical
databases (e.g., EDC systems) and ensure alignment with study
protocols and regulatory requirements. Collaborate with
cross-functional teams including Clinical Operations, Medical
Affairs, Regulatory Affairs, and Quality Assurance. Ensure
high-quality data collection, cleaning, and reporting processes.
Manage data management and biostatistics vendors and CROs, ensuring
deliverables are met on time and within budget. Develop and
maintain SOPs and best practices for biostatistics and data
management activities. Provide leadership and mentorship to data
management and biostatistics staff. This role will have direct
reports. Performs other duties as required. Education and
Experience: Master's degree in Life Sciences, Health Informatics,
Biostatistics or related field. Minimum of 8–10 years of data
management and/or biostatistics experience in clinical research,
with at least 3 years in a leadership role. Strong background in
medical device clinical trials and understanding of FDA and ISO
regulations (e.g., 21 CFR Part 11, ISO 14155). Knowledgeable in
statistical methods. Proficiency with clinical data systems (e.g.,
Medidata Rave, Oracle InForm, REDCap). Experience with device data
integration and analysis. Solid understanding of database design,
data standards (e.g., CDISC), and data quality assurance Excellent
communication, leadership, and project management skills.
Skills/Competencies: Excellent written and effective verbal
communication skills. Ability to communicate cross-functionally
across the organization. PC skills; word processing, spreadsheet,
database, Internet search and utilization. Flexible and able to
work in a fast-paced environment. Team player. Ability to organize
and judge priorities. Excellent ability to generate and maintain
accurate records. Powered by JazzHR LelhcumrDM
Keywords: GD Resources, Framingham , Clinical Director of Data and Biostatistics in Acton, MA - Locals Required, Science, Research & Development , Acton, Massachusetts
