Principal Statistical Programmer

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. Position is in India. We are experiencing exponential growth on a global scale and hiring Principal Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas.  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. As a Principal  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. How you will contribute: Performing data manipulation, analysis, and reporting of clinical trial data for 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 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 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 Complex macro writing General expertise with Figures Leading other programmers What you offer: 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. 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 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. 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 The opportunity to work with respected experts and thought leaders in the fields of biostatistics and statistical programming.