Principal Stats Programmer (VAX)

Overview

Principal Statistical Programmer within the Vaccines R&D value chain, delivering biostatistics and statistical programming for vaccines projects in the Hyderabad Hub.

What you'll do

• Plan and execute high-quality, timely statistical programming deliverables for vaccine projects.
• At study level, review protocol/statistical documents and create mock TLFs.
• Write programming specifications for SDTM/ADaM/TLFs and deliver compliant CDISC data packages with documentation.
• At project level, review integrated analysis plan, create mock TLFs, and build pooled integrated clinical databases.
• Ensure TLF formats meet targeted publishing and transparency requirements.
• Lead and guide junior staff, ensure quality/timely delivery, and perform QC for programming deliverables.

What you'll need

• 8+ years experience in statistical programming for clinical research, with some vaccines experience.
• More than 3 years of SAS experience with BASE, STAT, MACRO, GRAPH, SQL, and R.
• Experience programming CDISC SDTM/ADaM datasets, including specification writing and define.xml/Reviewers Guide.
• Ability to solve complex programming issues, including creation of complex macros and presenting alternatives.
• Experience pooling data from multiple studies and planning/drafting specifications for pooling.
• Consistent lead experience across multiple concurrent studies/projects and e-submission preparation experience is strongly preferred.
• Highly effective English communication (oral and written).

Details

• Location: Hyderabad.