Direct Data Management and Statistical operations.Develop structures and systems including: forms and reports templates, documentation standards, standard operating procedures, and work practice guidelines.Ensure Data Management and Statistical operations adhere to Standard Operating Procedures.Management and supervision of all SAS programming task allocated to the study program.Monitor the adherence to project timelines and relevant programming and quality standards.Oversee department and protocol budgets, staffing requirements, and equipment needs.Participate in the training for all new Stats and Data Department staff.Statistical Analysis of epidemiological and clinical trials using SAS®.Creation of Statistical Analysis Plans, Study report tables, listings and figures.Providing technical support, analyses and report writing of research results.The planning, creation and review of Statistical monitoring plans that includes study accrual safety reviews, accrual updates, futility analysis and efficacy comparisons.Ensure that the Quality Management Plan is maintained and adhered to.Develop ongoing employee training and mentoring programs

Statistical Analysis of phase I clinical trials using SAS®.Programming of statistical tables in SAS®.Create statistical analysis plans in accordance with the study protocol.The planning and design, statistical analysis, reporting, and publication of phase I clinical drug trial reports in accordance with good clinical practice and international standards.Work with data management to ensure a quality database by reviewing the proposed data checks, identifying any areas where additional data checks may needed to be built into reporting software, advising on ongoing questions from the sites regarding CRF completion.Work with statistical programmers to develop and program software required for statistical analysis.Prepare the data analysis for the clinical study report: review protocol deviations/violations, confirm the validity of the original statistical analysis plan, review the formal safety and efficacy tables produced by reporting statisticians.Liaise with sponsors to understand and help define requirements and finalize statistical analysis plans and study reports.Perform statistical work according to FARMOVS-Parexel and sponsor-specific Standard Operating Procedures and Working Instructions as appropriate to each project.

Statistical Analysis of phase III clinical trials using SAS®.Work with statistical programmers to develop and program software required for statistical analysis.Uses SAS software (BASE, STAT, GRAPH, MACRO) for the production of well formatted datasets, tables, listings, and figures, and outputs requested (e.g., patient profiles) per programming specifications, Statistical Analysis Plan, and other study related documentation.Performs Quality Control to ensure that outputs meet quality standards and project requirements. Works with Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.Perform statistical work according to Quintiles and sponsor-specific Standard Operating Procedures and Working Instructions as appropriate to each project.Develops specifications and mock-up display for outputs of any complexity according to statistical and sponsor requirement. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework