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Senior/Principal Statistical Programmer - FSP - (Remote)

Employer
Cytel - USA
Location
United States;Homeworking
Salary
Competitive
Start date
19 Jan 2022
Closing date
15 Feb 2022

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Job Details

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.

As a Senior Statistical Programmer, you will leverage your advanced SAS programming and strong CDISC (ADaM / SDTM) skills to lead and/or support one or more Phase I-IV studies, with a focus on Neurological Disorders. You will report to the Sr. Director, Statistical Programming.

You will contribute by:
  • performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
  • applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
  • generating complex ad-hoc reports
  • preparing and validating submission packages, i.e. define.xml, Reviewers Guide
  • applying your strong understanding/experience with Efficacy analysis;
  • preparing submission packages
  • 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 we are looking for:
  • Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • 7+ years of SAS programming experience in the Pharmaceutical & Biotech industry.
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Solid experience implementing CDISC Standards (SDTM/ADaM), including writing specifications and production/validation of datasets
  • Proficiency in SAS MACRO development
  • Strong AdaM dataset pooling for ISS/ISE
  • Strong ad-hoc reporting
  • Solid experience in Efficacy analysis
  • Experience with Pinnacle21
  • Submissions experience utilizing define.xml and other submission documents.
  • Oncology experience strongly desired.
  • 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.


What’s in it for you:

  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
  • You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
  • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
  • Work with and leverage the best and brightest minds in the industry

#LI-KO1

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