Senior Statistical Programmer Job at cGxPServe, Cambridge, MA

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  • cGxPServe
  • Cambridge, MA

Job Description

Responsibilities:
  • 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.
  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), 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 arts.
  • 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.
Requirements:
  • 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.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Solid experience implementing the latest CDISC SDTM / ADaM standards.
  • 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
  • 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.

Job Tags

Remote job, Flexible hours,

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