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Senior Principal Statistical Programmer
Location
North Carolina
Posted
6 days ago
Salary
$131.1K - $160K / year
Seniority
Senior
Job Description
Senior Principal Statistical Programmer
WCG
• Serve as a senior technical expert in statistical programming, providing guidance across multiple studies or functional areas. • Design, develop, validate, and oversee complex statistical programming deliverables, including analysis datasets, tables, listings, and figures. • Lead the development, validation, and continuous improvement of DMC macros and programming standards. • Provide technical oversight and review of programming work to ensure quality, compliance, and consistency across deliverables. • Drive the establishment and adoption of programming standards, best practices, and process improvements. • Collaborate with biostatistics and study teams to support complex trial designs, analyses, and DMC reporting. • Independently manage and prioritize programming activities across multiple studies or initiatives. • Mentor and provide technical leadership to statistical programming staff, supporting skill development and best practices. • Contribute technical expertise to proposals, project planning, and scope discussions as needed. • Partner with IT and technology teams to support SAS environments, tools, and system validation efforts. • Provide technical oversight for programming activities supporting regulatory submissions and inspection readiness. • Ensure programming deliverables align with regulatory expectations, submission requirements, and CDISC standards. • Influence programming approaches, standards, and best practices across multiple studies or programs. • Serve as a technical escalation point for complex programming, data, or deliverable issues, leading resolution of highly complex or ambiguous challenges. • Provide expert interpretation of statistical analysis plans (SAPs), protocols, and study documents, translating requirements into programming strategy. • Champion process improvements, automation, and innovative approaches to enhance efficiency, scalability, and consistency of programming deliverables. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
Job Requirements
- Minimum 8–10 years of statistical programming experience in a clinical trial environment
- Deep expertise in SAS programming, including complex analyses and regulatory deliverables
- Proficiency in R programming is a must
- Demonstrated experience with CDISC standards and regulatory requirements
- Proven ability to independently lead complex programming efforts across studies
- Experience mentoring staff and driving technical standards or best practices
- Demonstrated ability to independently coordinate biostatistical projects, including planning and oversight of programming activities, with minimal direction from senior leadership.
Benefits
- Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
- Employee Assistance Programs and additional work/life resources
- Referral Bonuses and Tuition Reimbursement
- Flexible PTO
- Volunteer Time Off to benefit the community
- Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
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