Senior Statistical Programmer
Hyderabad, Telangana, India
INR 1163K-1783K (estimate) Senior-level Full Time
Tasks
- Collaborate to harmonize data standards across studies
- Contribute to controlled terminology and metadata standards
- Create and maintain data transfer specifications
- Create and validate ADaM datasets per statistical analysis plan
- Develop and validate datasets in CDISC standards
- Develop metadata repository tools
- Develop tables listings and figures for clinical study reports
- Ensure adherence to regulatory requirements
- Ensure compliance with GxP and 21 CFR part 11
- Ensure metadata consistency traceability reusability
- Implement metadata driven transformation frameworks
- Integrate third party vendor data and map to CDISC
- Manage metadata authoring versioning publishing governance
- Perform validation and QC including double programming
- Support MDR lifecycle enhancements UAT change control
- Support statistical analysis and regulatory submissions
- Support validation documentation traceability matrices UAT execution
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | CDISC | CFR Part 11 | Data Transformation | Data Validation | Define-XML | Double Programming | GxP | Metadata Management | Part 11 | Quality Control | SDTM | Statistical Analysis | Statistical Analysis Plan | Tables Listings Figures | Traceability matrix | UAT
Education
N/A
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