Coordinate and approve Statistical Analysis Plans (SAP), mock-up tables, programming and derived dataset specifications developed by Biostatistics and Statistical Programming staff.
Lead protocol development work including experimental design, randomization, sample size calculation, statistical methods, defining study objectives and parameters.
Coordinate and approve the statistical section of the Clinical Study Report (CSR) written by Biostatistics staff, and collaborate with Medical Writer in preparing the integrated CSR as needed.
Coordinate and approve TFL and derived datasets, programming of derived datasets and Tables, Figures and Listings (TFL), and data review and statistical analysis developed by Biostatistics and Statistical Programming staff.
Provide management of other Biostatistics Department requirements and functions, such as SOP updates, as requested by line manager.
Serve as Quality Control Biostatistician for sample size calculation reports
Serve as IDMC / DSMB statistician as needed
Other duties commensurate with the position as assigned by line manager.
Provide staff training and study oversight as requested by line manager.
Provide staff oversight as mutually agreed with line manager.
Interpersonal and communication skills: Excellent written and oral communication skills including technical writing of all statistical results.
Ability to develop professional presentations for presenting statistical issues and solutions to clients internally.
Ability to effectively learn and handle new or unfamiliar statistical methods.
Ability to find needed written resources and interact with other Biostat staff with the needed familiarity.
Willingness to share expertise with younger staff members.