The lead statistical programmer is responsible for providing project leadership from statistical programming perspective in a cross-functional project team environment, and supports all the statistical programming aspects for assigned projects.
· Serve as lead statistical programmer to support the clinical programs, review or contribute to key Biometry documents to include but not limited to statistical analysis plans (SAPs) and TLF shells, data validation plan, programming specifications, and data analysis as appropriate.
· Responsible for providing strategic programming input to facilitate key reporting deliverables to include metadata, datasets, and TLFs.
· Support key data management activities to include CRF development, database build, data review and reconciliation, and database lock activities.
· Develop and validate/QC SAS programs for TLFs and SDTM/ADaM datasets associated with a clinical study, ad hoc report, submission, and publication.
· Ensure proper documentation and upkeep of programming metadata to include but not limited to programming specifications, reviewer guides, Pinnacle 21 reports, and define.xml.
· Develop/review TLFs and programming specifications in collaboration with Biometry and other clinical development colleagues as appropriate.
· Support oversight of vendors that conduct statistical work, including the production and QC of the statistical deliverables, ensuring accuracy, consistency, and quality output.
· Work closely with the Biostatistician and Data Manager during dry-runs to QC key efficacy and safety data and resolve identified data and programming issues.
· Contribute to the development and revision of statistics SOPs and process improvement.