Senior Statistical Programmer (Remote)

The Senior Statistical Programmer develops, validates, and documents SAS programs to support clinical trial data analysis and regulatory submissions. This role leads programming activities, ensures deliverables meet industry and regulatory standards, and mentors junior programmers. The Senior Statistical Programmer collaborates closely with cross-functional teams, troubleshoots data and programming issues, and advances process improvements to optimize project outcomes.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The accountabilities listed below are representative of the knowledge, skills, and/or ability required.

• Develop, validate, and document SAS programs for clinical trial datasets (SDTM, ADaM) and outputs (tables, listings, figures) for regulatory submission, ensuring accuracy and compliance.
• Lead programming activities and manage resources, timelines, and priorities for assigned studies and projects.
• Conduct comprehensive quality control checks and peer code reviews on all programming deliverables.
• Collaborate with statisticians, data managers, and clinical teams to ensure project requirements are met and deliverables are aligned.
• Conduct thorough quality control checks on programs and datasets to ensure precision and dependability.
• Oversee and manage programming activities for studies or projects, handling resource allocation, timelines, and budgets.
• Guide junior programmers, offering mentorship on industry standards and best practices.
• Provide expertise in interpreting and implementing Statistical Analysis Plan (SAP) programming specifications and project documentation.
• Troubleshoot programming and data issues, resolve discrepancies, and ensure timely, reliable data reporting.
• Coordinate multiple projects concurrently, setting strategic goals and adapting to evolving priorities.
• Foster innovation within the department and contribute to process enhancement initiatives
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS: Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field required.

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS: SAS Certification preferred.  

 QUALIFICATIONS/EXPERIENCE:

• At least 5 years of SAS programming experience required.
• R programming experience highly preferred.
• 2 years of macro programming experience required.
• At least 3 years of experience in the pharmaceutical, vaccines, biotech, or medical device industry required.
• Phase 1- 4 clinical trials experience.
• In depth knowledge of CDISC requirements required.
• Understanding of Statistical Analysis Plan programming specifications.
• Attention to detail, accuracy, initiative, and excellent communication skills are essential, as well as the ability to juggle several complex tasks simultaneously.

TRAVEL REQUIREMENTS:   

Physical and Sensory Requirements: The physical and sensory requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding).  Majority of time is spent in a seated position with frequent opportunity to move about at will.  Activities require a variety of easy muscle movements.  Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively.  There will be a need to attend to single or simultaneous tasks where accuracy of details is important.  The need for detailed and precise work is high.