Vishal Mahale

WORK HISTORY

EDUCATION

SKILLS

ABOUT VISHAL MAHALE

Responsible for applying, managing, and overseeing all aspects of clinical statistics and programming, including managing statistics/programming tasks performed by vendors, interfacing with in-house staff and in maintaining global data and analysis standards and department procedures.• Responsible for all aspects of statistical planning, methodology, and analysis or oversight of such tasks performed by an external vendor: Review CRF, database and dataset structure, 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). • Interface with in-house staff: Participate on 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.• Work with internal staff or vendors to assure that all programming and statistical analyses are properly conducted and validated to allow for proper analysis and interpretation required for inclusion into reports and regulatory submissions.• Assist Director, Biostatistics in identification, creation and maintenance of department procedures: Participate in departmental initiatives related to process building and improvement.• Work within SPARC, as necessary, to implement global programming and statistical analysis procedures, processes and standards.Perform statistical analyses of data and interpret results to ensure validity of conclusions.Generating Randomization and Sample Size Calculations.Write statistical methodology sections of protocols and Statistical Analysis Plans (SAP) to be carried out in the analysis of clinical studies. Review of draft documents.Respond to QA, Sponsor & Regulatory queries.