Senior Statistical Programmer

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

📋 Description

• Develop, validate, and document SAS programs for clinical trial datasets (SDTM, ADaM) and outputs (tables, listings, figures) aimed at regulatory submission while ensuring accuracy and compliance.

• Take charge of programming activities, managing resources, timelines, and priorities for designated studies and projects.

• Perform thorough quality control checks and conduct peer code reviews on all programming outputs.

• Collaborate effectively with statisticians, data managers, and clinical teams to meet project requirements and align deliverables.

• Execute meticulous quality control inspections on programs and datasets to guarantee precision and reliability.

• Supervise and manage programming tasks for studies or projects, overseeing resource allocation, timelines, and budgets.

• Mentor junior programmers by providing guidance on industry standards and best practices.

• Offer expertise in interpreting and implementing Statistical Analysis Plan (SAP) programming specifications and project documentation.

• Troubleshoot programming and data-related issues, resolve discrepancies, and ensure timely and reliable data reporting.

• Coordinate multiple projects simultaneously, establishing strategic objectives and adapting to shifting priorities.

• Encourage innovation within the department and contribute to initiatives aimed at process improvements.

• Perform other tasks as assigned by the supervisor, which may occasionally be unrelated to the described position.

⛳️ Requirements

• Minimum of 5 years of experience in SAS programming is required.

• Proficiency in R programming is highly preferred.

• A minimum of 2 years of macro programming experience is required.

• At least 3 years of experience in the pharmaceutical, vaccines, biotech, or medical device sectors is mandatory.

• Experience in Phase 1-4 clinical trials is necessary.

• Extensive knowledge of CDISC requirements is required.

• Familiarity with Statistical Analysis Plan programming specifications is essential.

• Strong attention to detail, accuracy, initiative, and excellent communication skills are crucial, along with the ability to manage multiple complex tasks simultaneously.

🏝️ Benefits

• Comprehensive benefits package including Health, Dental, Vision, Life Disability, 401k with matching contributions, and flexible spending accounts.

• Employee Assistance Programs and additional resources for work/life balance.

• Referral bonuses and tuition reimbursement opportunities.

• Flexible Paid Time Off (PTO).

• Volunteer Time Off to support community engagement.

• Opportunities for career growth through on-the-job training, certification support, and continuing education reimbursement.