Job Description
About the position Responsibilities • Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. • Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. • Ensure that data for statistical analyses are complete, accurate and consistent. • Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
• Ensure validity of analysis and explore alternative analysis strategies as needed. • Demonstrate extensive understanding of statistical concepts and methodologies. • Recognize and correct flaws in scientific reasoning and statistical interpretation. • Ensure accuracy and consistency of statistical tables, figures, and data listings. • Ensure accuracy of report text and consistency between summary tables in the body of reports and the corresponding source tables and listings. • Responsible for statistical methods section for the reports.
• Identify and correct common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assure project-wide consistency. • Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians. • Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work. Requirements • MS or PhD in Statistics, Biostatistics or related field.
• PhD with 3-5 years of experience or MS with 6-8 years of experience. • Strong experience with Oncology TA. • Strong oral and written communications skills. • Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations. • Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA. Apply tot his job Apply tot his job