Principal Statistical Programmer

This is a fully remote position, open to applicants in Washington.

📋 Description

• Take the initiative to develop, validate, document, and deliver SAS programming outputs for clinical trial analysis and reporting.

• Create or review programming specifications derived from Statistical Analysis Plans.

• Supervise the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer guides.

• Provide direct SAS programming support for critical analyses, data exploration, ad hoc requests, and internal or regulatory submissions.

• Follow study programming timelines, assess dependencies, recognize risks, and ensure alignment with cross-functional study objectives and milestones.

• Work in collaboration with Biostatistics, Data Management, Clinical Operations, and Safety teams.

• Evaluate data management plans, case report forms, data transfer specifications, vendor data specifications, and validation documentation.

• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components utilizing tools like Pinnacle 21.

• Lead the development and maintenance of SAS macros, utilities, programming standards, and reusable tools.

• Ensure compliance with CDISC standards, regulatory expectations, departmental SOPs, and best practices in statistical programming.

• Contribute to departmental initiatives, process enhancements, and cross-functional projects.

• Potentially take charge of statistical programming activities for designated clinical studies.

⛳️ Requirements

• A master’s degree or higher in Statistics, Computer Science, or a closely related programming field.

• At least 4+ years of relevant experience in the pharmaceutical or biotech industry.

• Comprehensive understanding of statistical programming principles, the clinical trial process, and regulatory requirements.

• Proficient knowledge of ICH, FDA, and GCP regulations and guidelines.

• Strong technical expertise in SAS, EDC systems, MS Word, Excel, PowerPoint, API-based data extracts, and ETL principles.

• Familiarity with CDISC, SDTM, CDASH, and ADaM industry standards.

• Strong problem-solving capabilities and skills in risk mitigation.

• Exceptional verbal, written, and interpersonal communication skills for effective cross-functional collaboration.

• Prior experience with NDA submissions and interactions with regulatory agencies is highly desirable.

• Previous experience in Oncology/Hematology is highly desirable.

🏝️ Benefits

• Medical, dental, and vision insurance for employees and their dependents, including 100% company-paid medical premiums for employees.

• A 401(k) plan with employer matching.

• Employer-funded life insurance, short-term and long-term disability insurance, and AD&D coverage.

• Paid time off, company holidays, and a week-long winter break between Christmas and New Year’s.

• Paid parental leave.

• Opportunity to contribute to the development of targeted cancer therapies.

• A collaborative and innovative work environment.