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.
...Piedmont Gardens, a 5-Star HumanGood Community in Oakland, CA is seeking an experienced Assistant Living (AL) Manager. Under general supervision of the AL Director, the AL Manager leads and manages the care & services team of twenty Resident Assistants, and serves as a...
...Description Local Drivers Needed ~ Hourly Rate (including overtime) PLUS pay for performance - Paid Time Off (PTO) plus holiday... ...for or if you are interested in the Travel Driver position your delivery areas will change based on needs (additional travel pay included...
...Job Description Job Description: Valet Attendant Reports to: Valet Manager. Position Summary: To project a professional image at all times. Provide valet parking and front door guest services for visitors and guests. Duties: Operate, park and retrieve all vehicles...
...Doctoral Degree (M.D.) Job Shift Flexible Schedule Job Category Physician Description Job Summary: Rothman Orthopaedics is seeking a Primary Care Sports Medicine providerto join our practice. The Non-Op Sports Medicine Physician will be based...
...across the organization. We are looking for an experienced Warehouse Associate - Shipper/Receiver to join our team at our Fridley Light Weight Belt Shop... ...Daily double-checking of picked orders at the shipping counter Daily packaging and processing of UPS/Speedy...