Principal Statistical Programmer
IND-Remote, India
R
INR 2243K-3020K (estimate) Senior-level Full Time
Tasks
- Develop SAS programming code for clinical outputs
- Develop and standardize programming tools and macros
- Develop dataset and output specifications
- Follow SOPs, WIs, and regulatory guidelines
- Generate summary tables data listings graphs derived datasets
- Lead statistical programming activities
- Maintain project documentation testing and quality control
- Manage scheduling across multiple projects
- Mentor programming personnel and provide training
- Participate in industry standards organizations
- Perform CDISC compliance reviews
- Perform electronic submission compliance support
- Perform validation programming
- Provide CDISC guidance and training
- Provide feedback to reduce programming inefficiencies
- Represent statistical programming in sponsor meetings kickoff and bid defense
- Resolve discrepancies with biostatisticians
- Review statistical analysis plan mock shells programming specifications and annotated CRFs
- Serve as technical expert for complex programming issues
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Analysis Plan | Annotated CRFs | CDISC | Clinical drug development | Clinical trials | Data Listings | Data Standards | Define-XML | Derived Datasets | Drug development | Electronic submissions | ICH | Mock Shells | Programming | Quality Control | S&OP | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Summary Tables | Validation programming
Education
Associate Degree | Bachelor of Engineering | Bachelor of Science
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