How you will contribute: - 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 What you offer: - 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 Rare diseases and Gastro Intestinal 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. Why Cytel? - Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry. - In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us! - Work with respected experts and thought leaders in the fields of biostatistics and statistical programming. Report this job
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