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Principal Programmer - SR

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Responsible for the integrity of the programming/computing solutions for a global clinical drug development program.Act as the scientific lead for programming expertise liaising with the Biometrician and statistical scientific counterparts within the team for a drug project. Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, publications, and market promotions within the drug development program globally.In conjunction with the Biometrician/Statistical Scientist, develop the project-level programming standards and ensure compliance with project-level/disease-area/company standards. As required, provide support to development of disease-area programming standards, following internal guidelines. Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities within the responsible drug project.Lead/program (according to established specifications) analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update) and for other project support (e.g. publications and market promotion) according to established milestones. Responsible for the preparation of Case Report Tabulations for the submission as required.In consultation with the Biometrician/Statistical Scientist, responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in RAP, MAP and CSPD) for the clinical drug project. Ensure QC compliance and responsible for project records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables for the drug project.Assume the role of subject matter expert / trial domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance. Mentor/coach programmers in functional expertise and process for project support; as required, support training/development of new programming applications.As required, participate in process improvement initiatives or other non-clinical project activities. Develops advanced MACROs for general use of programmers.Maintain up-to-date advanced knowledge of programming software (e.g., SAS/R/Splus).
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 6-11


Bio-Statistician | Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
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