Position Details
About this role
This role involves leading the development and oversight of clinical data standards and regulatory submissions within a biostatistics research department. The candidate will manage teams, ensure compliance, and collaborate with regulatory agencies.
Key Responsibilities
- Lead data standards team
- Ensure regulatory compliance
- Manage clinical data submissions
- Collaborate with stakeholders
- Mentor staff
Technical Overview
Expertise in CDISC standards, SDTM data model, statistical programming, and regulatory submission processes. Experience with clinical trial data analysis and regulatory guidance is essential.
Ideal Candidate
The ideal candidate is a senior biostatistician or data standards expert with over 10 years of experience in clinical data analysis, regulatory submissions, and CDISC standards. They possess strong leadership skills and a deep understanding of regulatory requirements for medical research.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 10 years of experience in analysis/reporting, No experience with CDISC or SDTM, Lack of regulatory submission knowledge, No leadership or managerial experience
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