Principal Stats Programmer (VAX)
Opella Healthcare Group (company site, opens in a new tab)8+ yrsHyderabadOn-siteDirect career pageEst. 20–32 LPA
Posted 18h ago
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Job description
Structured overview of role & requirements
About This Role
- Plan and execute high-quality, timely statistical programming deliverables for vaccine projects covering pre-clinical to translational stages.
- Lead and guide junior staff in delivering compliant CDISC data packages and integrated clinical databases across multiple studies.
- Perform quality control and documentation for statistical programming outputs, ensuring adherence to SOPs, standards, and regulatory expectations.
Minimum Requirements
- 8+ years experience in statistical programming for clinical research with some vaccines exposure (designs, endpoints, methods).
- Expert SAS skills (BASE, STAT, MACRO, GRAPH, SQL) and familiarity with R; experienced in CDISC SDTM/ADaM datasets for vaccines including metadata and define.xml.
- Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related health sciences, or equivalent experience.
- English communication: highly effective oral and written skills.
Ideal Candidate Profile
- Experience leading several concurrent clinical vaccine studies/projects with a strong project management capability.
- Proven ability to create and review statistical and integrated analysis plans, mock TLFs, and complex programming solutions including macros.
- Familiarity with clinical trial processes, e-submission preparation, and integration of multi-study datasets for regulatory submissions.