Principal Statistical Programmer - FSP - Remote USA or Canada

Date: Feb 12, 2024

Location: US

Company: Cytel Software Corporation

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.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.