The Principal Statistical Programmer leads multiple statistical programming activities as they relate to clinical research projects. Accountability includes the oversight and validation of study dataset creation and report generation (e.g., safety and efficacy analysis datasets, tables, listings, and figures). As an expert in the Statistical Programming team, the Principal Statistical Programmer provides technical expertise for the solution of programming issues and to the development of programming standards, procedures, and staff. Responsibilities also include mentoring junior programmers and leading the team when working with sponsors on technical process and requirements.
Statistical Programming
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data.
- Lead the creation of specifications and validation for SDTM domains, ADAM datasets, and Define.xml files.
- Responsible for management of assigned team members including task allocation, timelines, and completion.
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Review and sign off output across programs to ensure consistency.
Subject Matter Expertise
- Provide technical oversight and leadership in the areas of statistical programming.
- Serve as the primary project team representative for critical studies, delegating work as appropriate.
- Lead process improvement initiatives and the development of departmental programming procedures and standards to improve programming efficiency.
- Represent the statistical programming group in cross functional working groups.
- Provide input into assessments of resource requirements and time and cost estimates for statistical programming activities.
Personnel Mentorship
- Promote team development by providing coaching, mentorship, and training.
- Develop and deliver ongoing training on statistical programming systems and processes to peers and stakeholders.
- Provide feedback to management on the development of staff to assist in personnel development.
Qualifications
- Minimum of an undergraduate degree and 7-9 years of related experience.
- Excellent understanding of regulatory requirements in pharmaceutical industry and CRO environment.
- Extensive experience in SAS, with strong programming skills.
- Excellent knowledge of the CDISC data standards and experience in creating SDTM and ADaM datasets
- Excellent written and verbal English to accurately communicate statistical and data issues to statisticians, programmers, clients, as well as internal team members.
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Last updated on May 28, 2024