Job Description
Title: Principal Programmer – FSP – Permanent – Remote
Location: Remote, US, US or Canada
Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!
Cytel provides unrivaled 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 Sr. Director, Biostatistics 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:
- Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define
- Able to independently write specifications for and develop or validate SDTMs & ADaM domains with little or no oversight.
- Able to independently develop or validate TLF programs with little or no oversight.
- Able to manage programming activities and assignments for multiple studies
- Ability to communicate issues or risks promptly
- Willingness and ability to take initiative
- Excellent organizational, analytical, and problem-solving skills, ability to prioritize tasks, as well as excellent written, verbal, and interpersonal communication skills
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, 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
- Experience in vaccine clinical trials is an asset.