Principal Statistical Programmer

• 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 to 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 for clinical development programs
• 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
• 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

• 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 tools other than SAS, such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git

• Consistent training, development and support
• Significant professional growth opportunities