Senior Statistical Programmer

Job Summary:

Summarize the overall function of the work and capture the essence of the job. This is the statement of the reason why the position exists and expected results. Should be clear and concise and not reiterate the Job Details. This may be easier to summarize after writing the Job Details.

The Senior Statistical Programmer develops, validates, and documents statistical analysis 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.

Job Details:

Job Details should outline the essential functions of the role (five to seven). Statements should be action oriented -- start with action verb, describe what action needs to be taken and what is the outcome, in measurable terms. Not every task needs to be outlined, focus on main responsibilities.

Main Responsibilities

% of Role

Perform and support statistical programming activities, including the development, validation, documentation, and troubleshooting of statistical programs for clinical trial datasets (SDTM/ADaM) and outputs (tables, listings, and figures) supporting regulatory submissions and publications, ensuring timely delivery of high quality and reliable deliverables.

30%

Conduct comprehensive quality control checks and peer code reviews of programming deliverables to ensure accuracy, consistency, reliability, and compliance with regulatory requirements and programming standards.

15%

Collaborate with biostatisticians, data managers, and clinical operations, medicais affairs, and other cross-functional teams to ensure project requirements are met and deliverables are aligned with project timeline and quality expectations.

15%

Act as the lead statistical programmer for assigned device types or therapeutic areas, providing technical leadership by directing programming activities, coordinating multiple concurrent projects, monitoring project progress and deliverables, and mentoring junior programmers to promote programming excellence and adherence to industry standards and best practices.

20%

Review project documentation, including Statistical Analysis Plans (SAPs), mock TLF shells, programming specifications, CRFs, and database design specifications, providing proactive and strategic feedback to optimize programming efficiency, enhance data quality, and reduce rework and implementation risks.

10%

Drive innovation within the department by leading process improvement and operational efficiency initiatives, promoting best practices, standardization, and continuous improvement across statistical programming activities.

10%

Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Organizational Impact:

Describe the nature and scope of the role’s influence and impact within the organization. Include responsibilities related to budget, business operations, or departmental performance. Clarify how this role contributes to company objectives or operational success.

Example: Supports production efficiency and product quality by driving process improvements. Decisions directly influence output quality and production cycle time.

Supports business objectives by enabling efficient clinical data analysis, regulatory submissions, and evidence generation through robust programming practices and adherence to applicable standards.

Communication & Influence:

Explain the types of communication required and the audiences the role interacts with (e.g., peers, leadership, external stakeholders). Specify whether the role influences decisions, negotiates, persuades, or simply exchanges information.

Example: Frequently presents departmental updates to senior leadership; negotiates service-level agreements with external vendors.

Regularly communicates and collaborates with biostatisticians, data managers, project manager, and clinical teams to ensure project requirements are clearly understood and that deliverables are aligned with project objectives and timelines. Works with internal team members and statistical programming management to establish accurate timelines and effort estimates for study programming activities and ensures project deliverables are completed within agreed-upon timelines. This role does not involve negotiation with external parties; however, it provides data and analytical outputs that support informed decision-making.

Innovation & Complexity:

Describe the problem-solving nature of the role, including whether problems are routine, varied, or undefined. Highlight whether the role is expected to develop new solutions, improve processes, or manage ambiguity.

Example: Develops custom data models to address new business questions; regularly faces ambiguous or multi-variable challenges without precedent.

Applies technical expertise and innovative approaches to solve complex programming challenges and improve clinical reporting processes. The role provides the development and implementation of standardized programming practices, automation solutions, and process enhancements to increase efficiency and quality. The position requires adaptability in managing evolving requirements, complex study designs, and regulatory expectations while developing solutions that support successful clinical program execution.

Leadership & Autonomy:

Detail the level of people management (if any), including supervision, coaching, or team leadership. Clarify how independently the role operates and the authority to make decisions.

Example: Leads cross-functional project teams without direct supervisory responsibility; provides mentorship and technical guidance to junior staff. Makes independent decisions on process improvements and workflow management.

Leads programming activities without direct supervisory responsibility and provides mentorship and technical guidance to junior staff. Exercises independent judgment in driving process improvements and managing workflow activities.

Position Requirements:

Knowledge, Skills and Abilities (KSAs): Knowledge

is the comprehension of a body of information acquired by experience. Skills are present, observable competence to perform a learned activity; Abilities are the competence to perform an observable behavior or a behavior that results in an observable product or outcome.

Background Experiences:

Specify the minimum levels necessary to produce acceptable performance results, as required by the Job Details and activities performed. Include formal education and/or years of relevant work experience and any certifications or domain-specific expertise if relevant.

• Bachelor’s degree, preferably in a scientific, statistical, or related discipline, with a minimum of 5 years SAS programming experience in pharmaceutical, biotechnology, CRO, or medical device industry, or an equivalent combination of education, training and relevant experience.
• Extensive programming experience in SAS or other relevant software required, preferably within a clinical trial or regulated environment.