Senior Manager, Statistical Programming

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

📋 Description

• Lead statistical programming efforts for one or two designated clinical studies throughout the entire study lifecycle.

• Create and/or evaluate programming specifications based on the Statistical Analysis Plan.

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

• Provide direct SAS programming assistance for critical analyses, data exploration, ad hoc requests, and both internal and regulatory deliverables.

• Manage programming timelines for studies, coordinate dependencies, identify potential risks, and ensure alignment with cross-functional study plans and milestones.

• Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety teams.

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

• Oversee CRO statistical programming activities and assess outputs for accuracy, compliance, and timely delivery.

• Validate datasets, TLFs, and submission components generated by CROs using tools like Pinnacle 21.

• Develop and maintain SAS macros, utilities, programming standards, and reusable tools.

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

• Mentor junior programmers or contractors.

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

⛳️ Requirements

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

• At least 6+ years of pertinent experience in the pharmaceutical or biotech industry.

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

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

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

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

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

🏝️ Benefits

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

• A 401(k) plan with employer matching contributions.

• Employer-sponsored life insurance, short- and long-term disability insurance, and accidental death & dismemberment (AD&D) coverage.

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

• Paid parental leave.