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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 Oncology projects and utilizing your CDISC knowledge and advanced statistical programming capabilities.
This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel.
The Senior Statistical Programmer works in a team environment and provides technical input to clinical trials support to team members. In addition, the Principal Statistical Programmer fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.
Key Responsibilities:
- Provides technical input and support in developing SAS programs to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format.
- Provides technical input and support to create, review, and approve SDTM and AdaM specifications and datasets, and the associated documentation required to support data analysis, reporting, and CDlSC data submission.
- Serves as the production programmer for SDTM and AdaM datasets and provides critical review of specifications.
- Provides leadership to ensure compliance with company SOP’S and FDA/ICH/GCP regulations
- Participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with more significant consequences and impact
- May perform quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers
- Performs review on define.xml and create reviewers guide for ADaM datasets
- Review, maintain study documents per standard process
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
Technical and Communication Skills:
- Oncology experience and figure programming is a plus
- Experience with BLAs, MAAs and other regulatory submissions
- Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
- Excellent and transparent communication skills and ability to influence across multiple functions
Preferred Education and Experiences:
- BS or MS in technical field, with 6+ years of experience in pharmaceutical industry.