Principal Programmer

Principal Statistical Programmer (FSP)

Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.

We are hiring a remote Principal Statistical Programmer to support programming activities for clinical studies and submissions ensuring compliance with SOPs to produce quality and timely deliverables.  This position is a fully hands on role and reports to the Senior Director of Biostatistics.

How you will contribute:

• Performing lead programming activities for assigned clinical studies in collaboration with the client lead
• Independently designs and creates SAS programs for assigned project(s), consistently meeting objectives of the deliverables
• Codes complex SAS programs to analyze and report clinical trial data
• Works closely with biostatistics team to create ADaM datasets and TFLs to support study needs or submissions
• Reviews (or creates) specifications for analysis datasets, and TFLs
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
• Ensuring elements of submission data package are complete / experience reviewing define documents
• Review, maintain study documents per standard process
• Production and QC / validation programming
• Applying strong understanding/experience of Efficacy analysis in oncology studies
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Serving as team player, with a positive mindset of working together
• Being open, 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 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
• Advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
• Advanced experience working with CDISC SDTM/ADaM datasets
• Good working knowledge of oncology clinical trials
• Experience with BLAs and other regulatory submissions
• Proficiency in efficacy analysis and survival analysis
• Take initiative to question specifications or data issues and drill in on details of data issues
• Strong familiarity with drug development life cycle
• 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.