FSP-Principal Programmer at Cytel

Title: FSP-Principal Programmer

Location: US

Position is home-based in North America (U.S. & Canada).

How you will contribute:

• Acting as a lead programmer on several different projects while being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables
• Be an expert solution provider, guide & mentor statistical programmers to develop and manage high performing teams
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating, validating, reviewing 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
• Generating, validating, reviewing submission packages
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change

What you offer:

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
• At least 10 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 8 years of related experience with a master’s degree or above.
• Consistent experience as a lead statistical programmer on several concurrent projects
• 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 GI, Rare diseases, Hematology studies is 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!
• Work with respected experts and thought leaders in the fields of biostatistics and statistical programming