Senior Principal Statistical Programmer

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

📋 Description

• Act as a senior technical authority in statistical programming, offering guidance across various studies or functional areas.

• Create, develop, validate, and supervise intricate statistical programming deliverables, such as analysis datasets, tables, listings, and figures.

• Spearhead the development, validation, and ongoing enhancement of DMC macros and programming standards.

• Provide technical oversight and review of programming tasks to guarantee quality, compliance, and consistency in deliverables.

• Lead the establishment and implementation of programming standards, best practices, and process enhancements.

• Collaborate with biostatistics and study teams to aid complex trial designs, analyses, and DMC reporting.

• Independently oversee and prioritize programming tasks across multiple studies or initiatives.

• Mentor and offer technical leadership to statistical programming personnel, fostering skill development and best practices.

• Contribute technical knowledge to proposals, project planning, and scope discussions as necessary.

• Partner with IT and technology teams to facilitate SAS environments, tools, and system validation initiatives.

• Provide technical oversight for programming tasks supporting regulatory submissions and inspection preparedness.

• Ensure programming deliverables meet regulatory expectations, submission criteria, and CDISC standards.

• Influence programming methodologies, standards, and best practices across various studies or programs.

• Serve as a technical escalation point for intricate programming, data, or deliverable challenges, guiding the resolution of highly complex or ambiguous issues.

• Offer expert interpretation of statistical analysis plans (SAPs), protocols, and study documentation, translating requirements into programming strategies.

• Advocate for process enhancements, automation, and innovative strategies to improve efficiency, scalability, and consistency of programming outputs.

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

⛳️ Requirements

• At least 8–10 years of statistical programming experience within a clinical trial setting.

• Extensive expertise in SAS programming, including complex analyses and regulatory deliverables.

• Proficiency in R programming is essential.

• Demonstrated experience with CDISC standards and regulatory expectations.

• Proven capability to independently lead complex programming projects across studies.

• Experience in mentoring staff and promoting technical standards or best practices.

• Proven ability to independently coordinate biostatistical projects, including planning and oversight of programming activities, with minimal guidance from senior leadership.

🏝️ 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.

• Flexible PTO.

• Volunteer Time Off to support community involvement.

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