Principal Statistical Programmer FSP
Cytel View all jobs
- India
- Permanent
- Full-time
- Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
- Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
- Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
- Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
- Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
- Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
- Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Participate in the development of CRFs, edit check specifications, and data validation plans
- Provide review and/or author data transfer specifications for external vendor data
- Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
- At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred
- 8+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
- Proficient in programming using analytical software such as SAS and R
- Hands-on experience across the full spectrum of statistical programming activities, including but not limited to:
- SDTM and ADaM specification creation and review
- SDTM and ADaM dataset development
- TLF programming
- Define.xml and reviewer's guide creation
- Skilled in developing macros tailored to project needs
- Demonstrated ability to work independently with minimal supervision from study or asset leads
- Strong sense of ownership and accountability for assigned tasks
- Effective communicator who proactively engages with the team
- Capable of offering process improvement suggestions to the study team
- Active participation in programming team meetings and collaborative discussions
- Prior experience working in a global team environment
- Familiarity with CDISC standards and regulatory submission requirements
- Experience supporting FDA, EMA, and PMDA submissions
- Ability to manage multiple studies simultaneously
- Strong documentation and organizational skills