Associate Vice President, Biostatistics and Data Management (SPARC)
The Associate Vice President, Biostatistics and Data Management, is responsible for applying, managing, and overseeing all aspects of clinical statistics, programming, and data management for SPARC, including managing statistics/programming/DM tasks and budget, interfacing with in-house staff/senior management and in maintaining global data/analysis standards, regulatory compliance and department procedures.
Responsible for all aspects of data management, programming, and statistical planning, methodology, and analysis or oversight of such tasks performed by an external vendor: Perform clinical database build with all related processes, design database and dataset structure, create Data Management Plan, Data Quality Plan, Data Review Guidelines and edit specifications; Provide input into clinical study protocol and create/review/approve statistical analysis plan (SAP) and its implementation.
Interface with in-house staff: Participate on Senior Management Team and Project Teams; Review monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor(s) and KOLs to design statistically sound and viable clinical trials, participate in Clinical Department Review Committee, lead global heads of statistics, data management, and programming.
Work with internal staff or vendors to assure that all data management, programming and statistical analyses are properly conducted and validated to allow for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
Responsible for the identification, creation and maintenance of department procedures: Participate in departmental initiatives related to process building and improvement.
Work within SUN, as necessary, to implement global data management/programming/statistical analysis procedures, processes and standards.
Work with senior leadership on strategic planning, external collaborations, due diligence activities, organizational changes, and business development.
Performed as a clinical statistician for multiple clinical trials with submission experience and interaction with regulatory authorities
Experience with various clinical databases, specifically EDC systems
Experience exhibiting SAS programming skills and ability to apply these to statistical analyses and novel applications of statistics
Familiar with CDISC and AdAM standards, compiling data packages for submissions
Experience with power and sample size calculations and a wide variety of study designs for Phase 1-3 programs
Ph.D. in statistics a plus with 10+ years of related experience or M.S. in statistics with 15+ years of related experience
Excellent Mathematical Skills and Problem Solving Skills
Expert in SAS programming with demonstrated experience using Base SAS, SAS Stat, many Statistical Analysis procedures, Reporting and Graphical Procedures, Macro, SAS Version 9.2 or higher in a clinical trials setting