$200K — $250K *
Lead the biostatistics function and all biostatistics activities in clinical development and medical affairs. Take active role in supporting clinical trials from strategy, trials, approval and commercial support. Support design of clinical trials, estimate sample sizes, select appropriate statistical methodologies. Support generation of statistical section of study protocols, statistical analysis plans, data review, clinical study reports and regulatory submissions. Perform statistical analysis and analysis QC. Support adhoc analysis required for medical affairs activities, manuscripts, abstracts and regulatory communications. Oversee statistical work performed at CRO's. Ensure compliance with regulatory guidelines. Provide input to CRF design, database development, CSR writing. Oversee statistical deliverables for data monitoring committees.
Skills, Education and Experience:
Position Location and/or Territory and Travel
Valid through: 8/13/2020