Director, Statistical Programming
Tasks
- Coordinate cross functional reporting deliverables
- Develop advanced SAS programs and reusable macros
- Ensure 21 CFR Part 11 compliant submissions
- Evaluate programming automation and emerging technologies
- Lead regulatory submission programming deliverables
- Lead statistical programming across clinical studies
- Manage controlled terminology mapping
- Mentor programmers through code review and coaching
- Perform ISS and ISE analyses
- Perform QC and secondary review of SAS code
- Prepare eCTD ready SDTM and ADaM
- Represent statistical programming in regulatory interactions and audits
- Review SAP and develop TFLs
- Standardize programming processes and author SOPs
- Transform raw data into CDISC datasets
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical Trial Data | Clinical trial | Controlled Terminology | Data Capture | Define.xml | ECTD | Electronic Data | Electronic data capture | Interactive Web Response System | MedDRA | Metadata | Part 11 | Programming Automation | Python | QC | R | S&OP | SAS | SAS Graph | SAS Macro | SAS SQL | SAS Stat | SAS programming | SDTM | Trial data | WHODD)
Education
Master of Arts | Master of Computer Science | Master of Science
Regions
Countries
States
Cities
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