FSP-Principal Programmer at Cytel
Title: FSP-Principal Programmer
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.
- 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