Senior Statistical Programmer

Jobtailor; California (MO); On-site; USD 85,000 - 125,000; Full time

Job summary

Jobtailor is seeking a skilled Statistical Programmer to join our clinical data programming team. You will ensure the integrity of programming solutions, generate outputs for trials, and support regulatory submissions, publications, and promotions.

You will maintain validated programs and assist with ad hoc analyses across multiple projects. The role requires strong knowledge of R or SAS, 3+ years of experience, and a bachelor’s degree in statistics, computer science, or life sciences.

Qualifications

• Ability to program, document, and validate statistical software code in R or SAS.
• 3+ years of relevant programming experience with a Bachelor’s degree in a related field, or 1+ year with a Master’s degree.
• Bachelor’s degree or equivalent in Statistics, Computer Science, Life Sciences, or related field.
• Experience with regulatory submissions/regulatory guidelines (GCP, ICH).
• Demonstrated competence in statistical programming for clinical trials.

Responsibilities

• Ensure integrity of programming solutions for assigned projects.
• Lead production output generation for statistical reports, CSR, and regulatory submissions; support publications and market promotions.
• Create datasets, tables, figures, and listings for trials and submissions; assist ad hoc analyses.
• Provide programming support for supplemental analyses and internal/external requests.
• Maintain program libraries; ensure QC compliance and documentation archiving.
• Ensure audit readiness of programming deliverables; identify improvement opportunities.
• Collaborate cross-functionally and lead ad hoc teams when needed.

Skills

Statistical Programming

Experience in Programming

Data Analysis

Communication Skills

Education

Bachelor’s degree in Statistics, Computer Science, or Life Sciences

Tools

R

SAS

Job description

• Responsible for the integrity of the programming/computing solutions for all assigned projects.
• Support/Lead the full execution of final production output generation of quality, timely programming deliverables for statistical reports, CSRs, regulatory submissions, publications, and market promotions within the clinical projects.
• Generate analysis datasets, tables, figures, and listings for clinical trials, regulatory submissions, and ad hoc project support (e.g. publications and market promotions).
• Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad hoc requests.
• Ensure QC compliance and responsible for program records including archiving of programming and associated documentation.
• Responsible for quality control and audit readiness of quality programming deliverables.
• Establish and maintain libraries of clear, fully documented and validated programs/macros, which are used and recycled.
• Identify and work to implement process improvement initiatives.
• Establish and maintain sound working relationships with other functional groups.

Requirements

• Ability to program, document, and validate statistical software code in at least one statistical programming language, such as R or SAS, is required.
• 3+ years of experience of relevant experience in programming is required with a Bachelor’s degree in Computer Science, Statistics, or Life Sciences or 1+ years of experience with a Master’s degree in Computer Science, Statistics, or Life Sciences.
• A minimum of a Bachelor’s degree required in Statistics, Computer Science, or Life Sciences or related field.
• Equivalent education or experience will be considered.
• Demonstrated competence in the application of statistical programming techniques used in clinical trials and regulatory submissions is required.
• Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH) is required.
• Basic understanding of statistical principals and analysis plans is required.
• Strong problem solving skills and attention to detail is required.
• Ability to recognize potential problems and take preventive steps.
• Ability to recommend solutions for more complicated or ambiguous issues for consideration.
• May lead an ad hoc team to resolve issues.
• Ability to identify process improvement opportunities within the function or across related functions and work or collaborate to implement them is required.
• Demonstrated capability of working on multiple projects at one time is required.
• Strong oral and written communication skills are required.
• Strong interpersonal skills are required.
• Specifically, cross-functional collaboration, listening, and negotiation skills are critical.

Core Competencies

Demonstrates expertise in statistical programming using R or SAS, ensuring quality control and compliance for clinical trials and regulatory submissions. Proven ability to lead projects, implement process improvements, and maintain effective cross-functional collaboration.

Highest-signal resume keywords

• Statistical Programming in R or SAS
• Quality Control and Audit Readiness
• Regulatory Compliance (GCP, ICH)
• Process Improvement Initiatives
• Cross-Functional Collaboration

ATS Optimization Keywords

Hard Skills

• Statistical Programming
• Data Analysis
• Programming Documentation
• Quality Control
• Statistical Techniques
• Data Management
• Programming Validation
• Dataset Generation
• Regulatory Submissions
• Clinical Trial Support

Soft Skills

• Problem Solving
• Attention to Detail
• Interpersonal Skills
• Oral Communication
• Written Communication

Industry Keywords

• Clinical Trials
• Regulatory Submissions
• Statistical Analysis Plans
• GCP
• ICH