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Principal Programmer

Date: Jan 14, 2022

Location: US CA

Company: Cytel Inc

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

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 a remote Principal Programmer to work with a pharma company’s internal team leading project efforts and providing your CDISC knowledge and advanced statistical programming skills. This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel.

 

Your Impact

This position plays a key role in the development of statistical programming strategies including outsourcing and oversight strategies, standards and processes.  Provide programming expertise and capabilities in support of clinical studies, global development programs, and regulatory submissions.

Major Responsibilities:

  • Leads and coordinates statistical programming activities for clinical projects and regulatory submissions
  • Creates or oversees SDTM and ADaM datasets, specifications for analysis, TFL programming, supporting documentation including tools like Pinnacle21 for clinical studies
  • Provides programming support for regulatory submission packages including responding to regulatory queries in collaboration with other statistical colleagues
  • Identifies vendor requirements and provides oversight of statistical programming services of external vendors to ensure timeliness, quality, and consistency of statistical programming deliverables for assigned clinical projects
  • Provides guidance to programmers and analysts in US and China
  • Manages timelines and risk assessments for global projects
  • Identifies resource needs based on project milestones and deliverables
  • Complies with all applicable regulatory requirements and procedures
  • Demonstrates problem solving ability and critical thinking

 

What we are looking for:

  • M.S. or B.S. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with at least 6 years of programming experience preferably in the biotechnology, pharmaceutical or a related sector 
  • Proficiency in statistical programming languages/software such as SAS, R, Spotfire etc
  • Thorough knowledge of regulatory requirements for electronic submission standards
  • Excellent interpersonal, leadership, and communication skills
  • Strong collaborative skills and ability to work with a cross-functional team
  • Strong project management skills

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 learn and grow your career
  • Work with and leverage the best and brightest minds in the industry

 


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