Principal Statistical Programmer
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Job Description
Principal Statistical Programmer delivering SAS and CDISC clinical-trial reporting for Cytel’s pharmaceutical client. Overseeing CRO programming and supporting regulatory submissions.
Responsibilities:
- Work fully embedded within one pharmaceutical client while supported by Cytel
- Work independently with concept-level instruction and very little supervision
- Track progress and provide expert technical support to team members
- Work on clinical development programs across different therapeutic areas
- Participate in overseeing CRO programmers and ensure consistent, high-quality data summaries
- Implement reporting and analysis activities for sponsor clinical trials
- Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies
- Develop SAS programs generating datasets, complex listings, tables, descriptive and inferential statistics, and complex graphs
- Develop, validate, and maintain SAS and/or R programs tailored to clinical development programs
- Oversee CRO statistical programming deliverables for multiple clinical studies and ensure timelines are met
- Support clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses
- Follow FDA regulations, good clinical practice, and electronic submission guidelines
- Create, maintain, document, and validate standards for programming tools, outputs, and macros
- Participate in CRF development, edit check specifications, and data validation plans
- Review and/or author data transfer specifications for external vendor data
- Collaborate with CROs, software vendors, clinical development partners, and internal functions
- Review and/or author SOPs and work instructions related to statistical programming
Requirements:
- At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
- 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team
- Experience supporting drug development, medical device development, or intervention studies
- Exceptional SAS programming skills and expertise in developing and implementing statistical programming procedures and processes in a clinical development environment
- Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
- Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities
- Must be able to work independently
- Outstanding written and verbal communication skills and strong leadership skills
- Preferred: prior work experience with pharmacokinetic data and the neuroscience field
- Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, or git
Benefits:
- Consistent training, development and support
- Significant professional growth
- Professional growth opportunities through staff development
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