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Job Title:
Director of Data & Biostatistics
Overview The Director of Data & Biostatistics will lead data operations and statistical strategy for clinical studies supporting medical device development. This role oversees clinical data systems, ensures data integrity and regulatory compliance, and directs statistical analyses to evaluate safety, efficacy, and key research objectives. This leader will guide cross‑functional teams and manage both internal staff and external vendors.
Key Responsibilities
Lead data management strategy and execution for medical device clinical trials.
Support study design and ensure accurate interpretation of clinical data to meet business needs.
Develop and oversee statistical analysis plans and ensure appropriate methodology.
Oversee design, validation, and maintenance of clinical databases (EDC systems) aligned with protocols and regulatory requirements.
Ensure high‑quality data collection, cleaning, reporting, and documentation.
Manage data management and biostatistics vendors/CROs, ensuring on‑time, on‑budget deliverables.
Develop and maintain SOPs and best practices for data and statistical activities.
Provide leadership, mentorship, and direct supervision to data management and biostatistics staff.
Collaborate closely with Clinical Operations, Medical Affairs, Regulatory, and Quality teams.
Perform additional duties as needed.
Qualifications
Master’s degree in Life Sciences, Health Informatics, Biostatistics, or related field.
8–10+ years of clinical data management and/or biostatistics experience, including 3+ years in leadership.
Strong background in medical device clinical trials and relevant regulatory standards (21 CFR Part 11, ISO 14155).
Proficiency with clinical data systems (Medidata Rave, Oracle InForm, REDCap).
Experience with device data integration and statistical analysis.
Strong understanding of CDISC data standards, database design, and data quality assurance.
Excellent communication, leadership, and project management skills.
Core Competencies
Effective written and verbal communication across functions.
Strong organizational and prioritization skills in a fast‑paced environment.
Ability to maintain accurate records and documentation.
Collaborative team player with flexibility and problem‑solving abilities.
Seniority level Director
Employment type Contract
Job function Analyst
Industries Medical Equipment Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
Director of Data & Biostatistics
Overview The Director of Data & Biostatistics will lead data operations and statistical strategy for clinical studies supporting medical device development. This role oversees clinical data systems, ensures data integrity and regulatory compliance, and directs statistical analyses to evaluate safety, efficacy, and key research objectives. This leader will guide cross‑functional teams and manage both internal staff and external vendors.
Key Responsibilities
Lead data management strategy and execution for medical device clinical trials.
Support study design and ensure accurate interpretation of clinical data to meet business needs.
Develop and oversee statistical analysis plans and ensure appropriate methodology.
Oversee design, validation, and maintenance of clinical databases (EDC systems) aligned with protocols and regulatory requirements.
Ensure high‑quality data collection, cleaning, reporting, and documentation.
Manage data management and biostatistics vendors/CROs, ensuring on‑time, on‑budget deliverables.
Develop and maintain SOPs and best practices for data and statistical activities.
Provide leadership, mentorship, and direct supervision to data management and biostatistics staff.
Collaborate closely with Clinical Operations, Medical Affairs, Regulatory, and Quality teams.
Perform additional duties as needed.
Qualifications
Master’s degree in Life Sciences, Health Informatics, Biostatistics, or related field.
8–10+ years of clinical data management and/or biostatistics experience, including 3+ years in leadership.
Strong background in medical device clinical trials and relevant regulatory standards (21 CFR Part 11, ISO 14155).
Proficiency with clinical data systems (Medidata Rave, Oracle InForm, REDCap).
Experience with device data integration and statistical analysis.
Strong understanding of CDISC data standards, database design, and data quality assurance.
Excellent communication, leadership, and project management skills.
Core Competencies
Effective written and verbal communication across functions.
Strong organizational and prioritization skills in a fast‑paced environment.
Ability to maintain accurate records and documentation.
Collaborative team player with flexibility and problem‑solving abilities.
Seniority level Director
Employment type Contract
Job function Analyst
Industries Medical Equipment Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr