Senior Statistical Programmer - Clinical Trials / Strong Ad-Hoc & Validation (Remote, US )

Company: Cytel Software Corporation
Location: Lees Summit
Posted on: August 4, 2022

Job Description:

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. 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.We are experiencing exponential growth on a global scale and hiringSenior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, tosupport or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas.How you will contribute:

• Performing data manipulation, analysis and reporting of clinical trial data, 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
• 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 What you offer:
  • Bachelors degree in one of the following fieldsStatistics, Computer Science, Mathematics, etc.
  • At least 8years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industrywith a bachelors degree or equivalent. At least 6years of related experience with a masters 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 would 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 benefits 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.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 Cytels 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.Required
      Preferred

      Job Industries

      • Customer Service

Keywords: Cytel Software Corporation, Lee's Summit , Senior Statistical Programmer - Clinical Trials / Strong Ad-Hoc & Validation (Remote, US ), Other , Lees Summit, Missouri