Principal Statistical Programmer
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Job Description
Principal Statistical Programmer embedded with a pharmaceutical client, developing SAS/R clinical-trial outputs. Supporting regulatory submissions, CDISC standards, and CRO programming oversight.
Responsibilities:
- Work independently on clinical development programs across different therapeutic areas
- Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies
- Develop SAS and/or R programs producing datasets, complex listings, tables, descriptive and standard inferential statistics, and complex graphs
- Develop, validate, and maintain statistical programming programs tailored to clinical development needs
- Oversee CRO statistical programming deliverables for multiple clinical studies
- Support clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses
- Follow FDA regulations, good clinical practice, and electronic-submission guidelines for clinical trial data reporting
- Create, maintain, document, and validate standards for programming tools, outputs, and macros
- Participate in developing CRFs, 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 to meet project timelines and goals
- Review and/or author SOPs and work instructions related to statistical programming practices
- Provide expert technical support to team members and track progress
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 regulations
- Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities
- Ability to work independently
- Outstanding written and verbal communication skills and strong leadership skills
- Preferred: prior experience with pharmacokinetic data and neuroscience
- Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, and git
Benefits:
- Consistent training, development and support
- Significant professional growth opportunities
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