The Principal Biostatistician serves a lead role on project and interacts with team members in designing and analyzing clinical trials. Key responsibilities and skills include, but are not limited to:

• 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.


• Responsible for accuracy and completeness of database quality assurance checks. and for assuring that data for statistical analyses are complete, accurate and consistent.


• Responsible for statistical analysis plans (SAP) and the accuracy/timeliness of statistical input into reports or decisions.


• Responsible for validity of analysis and alternative analysis strategies when circumstances change.


• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.


• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in reports and corresponding source tables and listings.


• Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures 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 so that projects are delivered on time with high quality.

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 oral and written communications skills, with ability to effectively communicate internally and with clients.


• 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.