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Responsibilities : Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS / Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets / analysis files, and tables, listings, and figures (TLFs). Production and QC / validation programming. Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP. Demonstrate good understanding of the endpoints and data collection. Generating complex ad-hoc reports utilizing raw data. Applying strong understanding / experience of Efficacy analysis. Creating and reviewing submission documents and eCRTs. Communicating with and / or responding to internal cross-functional teams and client for project specifications, status issues, or inquiries. Requirements : Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, or related fields. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Solid experience implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis, and reporting of clinical trials' data. Submissions experience utilizing define.xml and other submission documents. Experience supporting Rare Diseases and Gastrointestinal studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

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