Senior Statistical Programmer

December 12

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Clinical Outcomes Solutions

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Patient Reported Outcomes • Health Economics and Outcomes Research • Clinical and Observational Research Design and Execution • Outcomes Regulatory Support • Statistics and Psychometrics

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) • Production and QC / validation programming • 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 • Performing lead duties when called upon • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. • Being adaptable and flexible when priorities change

Requirements

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. • 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. • Strong SAS data manipulation, analysis and reporting skills. • Solid experience implementing the latest CDISC SDTM / ADaM standards. • Strong QC / validation skills. • Good ad-hoc reporting skills. • Proficiency in Efficacy analysis. • 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 immunology, respiratory or oncology 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.