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Senior Statistical Programming Consultant
Responsibilities:
- Develop and validate SDTM and ADaM datasets and produce tables, listings, and figures for individual studies and integrated summaries submitted to global health authorities
- Provide technical input during SAP and TLF specification development
- Own CRF annotation and dataset specification documentation across SDTM and ADaM standards
- Review and provide input on data collection instruments, vendor transfer specifications, edit checks, and related study documents
- Contribute programming support to clinical study reports, regulatory submissions, and ongoing safety reporting
- Conduct ad hoc and exploratory analyses for publications, presentations, and internal data review
- Oversee and collaborate with third-party programming vendors to ensure quality and consistency
- Help develop and maintain departmental SOPs, work instructions, and process standards
- Stay current with SAS developments and evolving industry best practices
Qualifications:
- Bachelor’s or Master’s degree in a quantitative or computational field; advanced degree preferred
- 6+ years of statistical programming experience in pharma or biotech
- Strong communicator able to work across functions, manage priorities, and meet deadlines
- Deep SAS proficiency in a GxP-regulated environment
- Solid track record with CDISC-compliant dataset development and full programming/validation cycles