Princicpal Statistical Programmer

Role & responsibilities

The Principal Stat Programmer plays a critical role in ensuring the accuracy and

integrity of statistical programming across various clinical projects. This position

demands proficiency in SAS programming and familiarity with CDISC standards,

particularly ADaM and SDTM models. The role re

quires experience in Safety and/or Efficacy analysis programming, including creation of

efficacy datasets and efficacy outputs, ADaM specifications writing, and regulatory

submission documentation. Key responsibilities include developing and validating

complex data sets and outputs, collab

orating with cross-functional teams to optimize processes, and providing technical

guidance on statistical methodologies and programming best practices. The role also

involves mentoring junior programmers and contributing to the continuous improvement

of programming workflows and standards, supporting the overall quality deliverables of

the statistical programming department.

Essential Functions

• Develops and validates complex datasets and outputs using SAS programming,

ensuring compliance with CDISC standards such as ADaM and SDTM models.

• Performs Safety and/or Efficacy analysis programming, including creation of efficacy

datasets and efficacy outputs (Tables, Listings, and Figures).

• Authors and reviews ADaM specifications for Safety and/or Efficacy analyses in

compliance with CDISC standards.

• Creates and maintains regulatory submission documentation including Analysis Data

Reviewers Guide (ADRG) and Define.xml.

• Utilizes Pinnacle 21 (P21) to validate datasets and ensure submission readiness and

compliance with regulatory requirements.

• Collaborates with cross-functional teams to optimize statistical programming

processes and enhance overall efficiency and accuracy.

• Provides technical guidance and expertise on statistical methodologies to support

clinical trial projects and departments.

• Mentors and guides junior programmers, fostering their growth and development.
• Contributes to the continuous improvement of programming workflows and

departmental standards.

• Ensures high-quality deliverables from the statistical programming department by

adhering to best practices and established protocols.

• Leads initiatives to enhance programming tools and techniques, driving innovation in

statistical programming.

• Partners with leadership to align programming objectives with larger organizational

goals.

• Utilizes R programming to support statistical analyses, automation, data manipulation,

reporting, and development of programming solutions where applicable.