Senior Statistical Programmer (Pharma/CRO, India)
Tasks
- Create BIMO outputs and define.xml
- Develop and apply ADaM specifications
- Develop and apply SDTM specifications
- Generate tables listings and graphs from clinical trial databases using SAS
- Lead study or small programming project teams
- Manage tasks and projects and guide junior colleagues
- Perform data set pooling for submissions
- Prepare ICH compliant deliverables
- Produce reviewers guides and SDSP deliverables
- Support E-Submission standards
- Utilize SDLC for programming deliverables
- Write SAS programs using SAS Base and SAS Macros
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | BIMO | CDISC | CFR Part 11 | Clinical trials | Data Set | Data Set Pooling | DefineXML | E-submission | HL7 | ICH | ISO 9001 | Part 11 | Pharmaceutical Development | Reviewers Guide | SAS | SAS Base | SAS Macro | SDLC | SDSP | SDTM | TLG
Education
Associate Degree | Bachelor of Engineering | Bachelor of Science | Master of Science
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