Position Details
About this role
This role involves supporting clinical trial data submissions, ensuring compliance with industry standards, and performing statistical programming for regulatory purposes.
Key Responsibilities
- Develop specifications and programs for data review
- Manage data standards compliance
- Generate SDTM/ADaM datasets
- Validate analysis datasets
- Support regulatory submissions
Technical Overview
Proficiency in SAS, R, Python, Unix scripting, and clinical data standards like CDISC, SDTM, and ADaM in a pharmaceutical/biotech clinical trial environment.
Ideal Candidate
The ideal candidate is a highly experienced senior statistical programmer with 8+ years in clinical trial data analysis, proficient in SAS, CDISC standards, and familiar with regulatory submission processes. Strong communication and collaboration skills are essential.
Must-Have Skills
None listed
Required Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with CDISC standards, Less than 8 years programming experience, No clinical trial environment experience
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