Development of Statistical Analysis Plan (SAP) or equivalent including Table Shells Design.
Provide statistical support for case report form design, database development, data validation plan and blinded data review as and when required.
Conduct literature searches to support statistical analysis.
With minimal or no oversight, perform statistical programming to generate tables, listings, figures, and statistical analysis for efficacy outputs.
Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health authorities.
Participate in client or regulatory audits.
Guide cross functional teams Data management and medical writers for all trial related activities
Any Graduate or Statistics graduate with 2+ years of experience in with analysis and reporting experience in clinical trials of which atleast 2+ years as Biostatistician.
Hands on experience of efficacy statistical programming using SAS
Proven Knowledge of Clinical Drug Development processes, regulatory requirements, technical standards.