Senior Statistical Programmer, FSP

Responsibilities

• Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generate and validate SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Produce QC / validation programming
• Generate complex ad‑hoc reports utilizing raw data
• Apply strong understanding/experience of Efficacy analysis
• Create and review submission documents and eCRTs
• Communicate with and/or respond to internal cross‑functional teams and clients for project specifications, status, issues or inquiries
• Perform lead duties when called upon
• Serve as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Be 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.
• Study lead experience, preferably juggling multiple projects simultaneously.
• 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.