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Principal / Lead Statistical Programmer

Cytel

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Principal / Lead Statistical Programmer

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 remote Principal Statistical Programmers for our growing FSP division.  Position reports to Director, Statistical Programming.  Excellent opportunity for a Senior Programmer to move into a Principal role.

 Your Impact 

As a seasoned Statistical Programmer, you will apply your strong ADaM development and validation experience, including Efficacy analysis, to mostly support IDV and Oncology studies.  This includes working with PK data and multiple study designs, such as 2-way, 3-way, 4-way or more crossover studies, single dose, parallel, dose escalation, Bioavailability, Bioequivalence, Renal/Hepatic Impairment, drug interaction, Absorption, Distribution, Metabolism, and Excretion (ADME).     

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. 
  • 6-8 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. 
  • Experience in AdaM dataset pooling for ISS/ISE
  • Solid experience implementing CDISC Standards (SDTM/ADaM) 
  • Proficiency in SAS  MACRO development
  • 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. 
  • Ability to work in a fast-past environment.

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
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