Senior Statistical Programmer

Job Title: Senior Statistical Programmer Location: India (Remote) / Hybrid (Open to Pune / Hyderabad) We are experiencing exponential growth on a global scale and hiring Senior 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 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. How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data and analysis datasets Applying strong understanding/experience of Efficacy analysis Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties for assigned clinical study under principle programmers oversight 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 Generating and validating Non-CDISC transformation datasets and analysis datasets Proficient knowledge with SDTM/ADaM and TLF’s. General expertise with Figures Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP. They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides. R & complex macro writing are a plus What you offer: Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 5+ 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. Strong SAS data manipulation, analysis and reporting skills. Strong QC / validation skills. Good ad-hoc reporting skills. Solid ADaM and complex TFL skills. Proficiency in efficacy analysis and survival 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 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.