Job description
Associate Director, Data Standard & Statistical Programming (Contractor)
Location: Remote
Job Summary
A fast-paced biotech organization is seeking an experienced Associate Director of Data Standards & Statistical Programming (DSSP) to lead statistical programming efforts across clinical programs. This contractor role will drive CDISC standards implementation, SAS macro development, and cross-functional collaboration with CROs, Biostatistics, and Data Management. The ideal candidate brings deep expertise in oncology trials, electronic submissions, and programming automation.
Responsibilities
This is a 12 month contractor assignment
Location: Remote
Job Summary
A fast-paced biotech organization is seeking an experienced Associate Director of Data Standards & Statistical Programming (DSSP) to lead statistical programming efforts across clinical programs. This contractor role will drive CDISC standards implementation, SAS macro development, and cross-functional collaboration with CROs, Biostatistics, and Data Management. The ideal candidate brings deep expertise in oncology trials, electronic submissions, and programming automation.
Responsibilities
- Lead statistical programming activities at both program and study levels
- Coordinate deliverables across multiple studies and functional teams
- Ensure implementation of the latest CDISC SDTM and ADaM standards
- Design, develop, and validate programs for clinical data analysis
- Oversee creation of clinical data listings, summary tables, figures, and Define.xml files
- Develop SOPs, work instructions, and departmental standards
- Mentor junior programmers and guide project-level execution
- Generate safety and efficacy outputs using SAS Base, Macros, STAT, Graph, SQL, ODS
- Create SDTM, ADaM datasets, SAS transport files, Pinnacle 21 reports, and reviewer guides
- Review TLF shells, Data Management Plans, validation plans, and edit check specs
- Contribute to statistical analysis plans and protocol-related data strategy
- Identify and resolve data inconsistencies
- Automate programming processes to improve efficiency and quality
- 4+ years in a small or mid-sized biotech environment
- 8+ years working with CDISC SDTM and ADaM standardsMaster’s degree in Mathematics, Statistics, Computer Science, or related field
- 12+ years of statistical programming experience in the biopharma industry with at least 4 years in oncology clinical trials, including RECIST endpoint derivation
- Proven experience leading NDA filings and integrated summaries (ISE/ISS)
- Advanced proficiency in SAS programming (Base, Macros, Graph, Stat)
- Familiarity with R or Python is a plus
This is a 12 month contractor assignment