Senior Programmer
Date: Nov 17, 2023
Location: US
Company: Cytel Software Corporation
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 Senior 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 of Biostatistics in the FSP Services business unit in Cytel.
Your Impact
This position plays a key role in the Statistical Programming Group and is responsible for developing software programs (SAS, R, and Python) for the analysis of Clinical Trial data in accordance with departmental SOPs and guidelines. The Senior Programmer position will work collaboratively with other programmers, biostatisticians, clinicians, data managers in the planning, conduct, and analysis of clinical studies in all phases.
Essential Functions:
- Represent the statistical programming function in the assigned projects
- Create, review, or approve programming plans and specifications at project and study level
- Program, according to specifications, analysis datasets, tables, listings, and figures for phase I-IV clinical trials and publications
- Review key study documents produced by other functions (e.g. CRFs, data management plans, SAPs, clinical study reports, etc.)
- Maintain efficient interfaces with internal and external customers and vendors with support of the collaborating statistician(s)
- Must be able to work independently on multiple projects concurrently
- Must be open to work in Agile programming environment
- Support quality control of deliverables related to statistical programming
- Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
Minimum Requirements
- BS or MS preferred in relevant life sciences, computer science or statistics/analytical field
- Minimum of 5 years of experience in developing programs for clinical trials using the SAS system
- Knowledge of statistics and drug development process
- Excellent proficiency in programming with SAS
- Proficiency in R, Rshiny, Python is plus
- Experience working with CDISC SDTM and ADaM compliant data sets
- Experience in pharmacokinetics/pharmacodynamics modeling a plus
Skills and Knowledge Requirements
- Experience in a matrix team environment
- Excellent written and oral communication skills and demonstrated problem-solving abilities
- Ability to work proactively while handling multiple deliverables and short timelines
- Computer proficiency in SAS, Microsoft Word, Excel, and PowerPoint
- Must be able to prioritize and multi-task, work effectively with little or no direction, and build collaborative relationships with management, partners, and peers from diverse backgrounds.
- Ability to work across multiple projects
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
- Understanding of study phases and general knowledge of how they apply to biostatics and statistical programming
- Demonstrated ability to work independently and in a team environment
- Ability to create and maintain of study-specific data management documents
- Ability to interface cross-functionally with Data Programming
- Ability to assist with the training of new study team members