Sr. Manager - Statistical Programming, Central Services
Tasks
- Collaborate with biostatisticians and data management
- Deliver programming outputs for clinical studies
- Develop statistical programming tools standards and best practices
- Drive process improvements for quality and efficiency
- Ensure compliance with regulatory standards
- Mentor team members and build capabilities
- Oversee integrated dataset development
- Prepare and review eCTD submission packages
- Provide technical leadership for statistical programming
- Support clinical trial transparency disclosures
- Support inspection readiness and regulatory queries
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | CDISC | Clinical Trial Transparency | Clinical trial | Define-XML | ECTD | Integrated Analysis | Pinnacle 21 | Python | R | SAS | SDTM | Statistical programming
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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