Perform activities with minimal supervisor’s instruction.
Oversee various statistical programming personnel.
Develop program for dataset integration from various sources or studies under supervision.
Prepare programming documentation incorporating plans and specifications suitable under statistical programmer supervision.
Prepare resource plans as needed with assistance of Group Head.
Prepare specifications for pooled datasets, analysis datasets and listings.
Assist quality control and audit of all statistical programming deliverables.
Maintain all records for every assigned project and prepare trial or project evaluation and related documentation.
Participate in CROs selection and monitor SR trial activities of CROs.
Provide input on entire process enhancement initiatives and involve in non-clinical project tasks.
Prepare, record , verify and maintain complex SAS-based evaluation and reports of clinical trials data.
Develop analysis statistical datasets, prepare summary tables, graphs and listings.
Review statistical datasets for developing NDA submissions.
Maintain all company standards for program validation and production.
Coordinate activities within Biometrics department along with collaborate with various Clinical Research areas.