Job Description

• 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.

• Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, or related field.
• 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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