Senior Statistical Programmer Fsp

1 day ago

India Cytel Full time

Job Category Statistical Programming - FSP 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 Responsibilities 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 Qualifications 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

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