At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Position is home-based in North America (U.S. & Canada), with option to work out of one of our office locations in King of Prussia, PA or Waltham, MA.

We are experiencing exponential growth on a global scale and hiring Principal Statistical Programmers to join our FSP division.  You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas.

Our values

• We believe in applying scientific rigor to reveal the full promise inherent in data.
• We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
• We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
• We prize innovation and seek intelligent solutions using leading-edge technology.

As a Principal 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.

How you will contribute:

• Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/ISE) utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs)
• Production and QC / validation programming
• Ability to program from scratch and able to handle complicated domains and TLF’s. Ability to read and apply protocol and SAP.
• Demonstrate good understanding of the endpoints and data collection.
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• 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
• R & complex macro writing are a plus

What you offer:

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, or related field
• 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 preferred.
• 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 Rare Diseases and Gastrointestinal 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.

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!
• The opportunity to work with respected experts and thought leaders in the fields of biostatistics and statistical programming.