Cambridge, MA, 02238, USA
10 days ago
Principal Statistical Programmer
**Sponsor-dedicated:** Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. **Position Overview:** As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. **Our values** + We believe in applying scientific rigor to reveal the full promise inherent in data. + We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. + We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. + We prize innovation and seek intelligent solutions using leading-edge technology. **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 \#LI-Remote #LI-RP1 **Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:** + 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.\#LI-Remote #LI-RP1
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