Sreedevi Pulipaka Email & Phone Number

Bridgewater, Nj, Us

Nashville, Tn, Us

Established the process and trained creating the define files for the SDTM and ADaM data. Created macros for Define process, created validation checks. Created the CDISC mapping specifications for the SDTM and ADaM datasets. Created and validated SDTM, ADaM and TLFs. Reviewed the final TLFs for consistency checks.

Westlake Village, California, Us

Florham Park, New Jersey, Us

Toronto, Ontario, Ca

Brentford, Middlesex, Gb

Shall provide statistical programming expertise (preferably in SAS) in the production of analyses, tabulations, graphics, and listings from clinical trial data. Key responsibilities and skills include, but are not limited to, the following: Contribute to the preparation of analysis plans. Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical. statistical reports and other similar reports. Contribute to the integrated clinical/statistical report and other similar documents. Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting. Perform quality assurance procedures on work performed by others. Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities. Assist in the integration of data from remote entry sites.

Marlborough, Ma, Us

Tarrytown, New York, Us

• Support and lead programmer for programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies. Support creation and validation of submission requirements (i.e. annotated CRF, data export files, define documents).Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, develop and provide department training for applications and standard tools developed by the department functions group. Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations. Participate in department working groups; provide input in development of tools and improvement of processes.

Brentford, Middlesex, Gb

Lead programmer for a Phase I Oncology study. Level 3 validation support for key efficacy analysis for a Phase III Oncology study, Supported the programming efforts for the VOTRIENT submission. Supported statistical programming group in deriving the analysis datasets, TFLs and daily adhoc reports. Oncology and Cardio Vascular therapeutic experiance.

Us

Supported programming team in creating/validatiing the clinical data. Programming support to clean the data, producing statistical reports, macros to support the statistical analysis. Worked on the REMICADE for psoriatic arthritis therapy.

Programming support in standardizing the CDISC SDTM post ETL data. Modified/created Edit checks for the SDTM mappings, dropping Null Permissible variables, format catalogue checks.

Ms, Mathematics With Computational Track

M.Tech, Informational Technology

M.Sc, Statistics