General Information

Location: Cary, NC, Remote

Organization: ACI Clinical

Job Type: Full Time - Regular

Description and Requirements

The expected base salary range for this position is $104,750-$128,000. This salary range may vary based on the candidate's qualifications, experience, skills, education, and geographic location.

JOB SUMMARY: The Senior Principal Statistical Programmer serves as a senior technical leader and subject matter expert in statistical programming, with deep expertise supporting clinical trials and Data Monitoring Committee (DMC) deliverables. This role combines advanced hands-on programming capabilities with technical leadership, driving the design, development, and standardization of high-quality statistical outputs. The Senior Principal Statistical Programmer independently leads complex programming initiatives, provides expert-level guidance across projects, and plays a key role in shaping programming standards, tools, and best practices. This role partners closely with biostatistics, project management, data management and cross-functional stakeholders to ensure high-quality, compliant, and efficient delivery of programming outputs.

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.

• 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.

EDUCATION REQUIREMENTS: Master's degree required. In limited circumstances, an equivalent combination of education and directly relevant professional experience may be considered.

QUALIFICATIONS/EXPERIENCE:

• 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.

TRAVEL REQUIREMENTS:
• 0% - 5%

5% - 10%

10% - 20%

20% - 50%

>50%

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.

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