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 Reviewer’s 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.

• Minimum 1 year of hands-on R programming experience is mandatory.
• Experience in Safety OR Efficacy analysis programming is required.
• Hands-on experience in creation of efficacy datasets and efficacy outputs (Tables, Listings, and Figures).
• Experience in ADaM specifications writing for Safety and/or Efficacy studies.
• Experience in creating Analysis Data Reviewer’s Guide (ADRG), Define.xml, and performing dataset validation using Pinnacle 21 (P21)

Qualifications

• Bachelor's Degree Statistics, Computer Science or related field Req
• Master's Degree Statistics or Computer Science Pref.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Ability to lead/manage others Capably leads and manages programming teams, ensuring adherence to standards and mentoring junior programmers.
• Demonstrated ability to maintain confidential information Maintains strict confidentiality of sensitive project data and internal communications.
• Demonstrates excellent judgment and decision-making skills Exercises sound judgment and decision-making in selecting statistical methods and programming techniques.
• Ability to work within tight timeframes and meet strict deadlines Effectively manages time and resources to deliver high-quality programming outputs within tight deadlines.
• Project Demonstrated project management skills Executes projects efficiently, demonstrating strong project management skills to coordinate tasks and resources effectively.
• Possesses strong technical aptitude Demonstrates robust technical aptitude with a deep understanding of SAS programming and CDISC standards.
• Ability to analyze and interpret financial data Analyses and interprets financial data accurately to make informed decisions in statistical programming.
• Demonstrated analytical skills Utilizes strong analytical skills to assess statistical programming requirements and ensure data integrity.
• Demonstrated problem-solving skills Applies effective problem-solving skills to overcome programming challenges and optimize workflows.
• Excellent interpretation of complex statistical data Interprets complex statistical data with proficiency, ensuring accurate construction and validation of clinical datasets.
• Demonstrated written communication skills Exhibits strong written communication skills to document programming methodologies and procedures clearly.
• Strong verbal communication and listening skills Communicates effectively with cross-functional teams to facilitate collaboration and improve statistical programming processes.
• Instills commitment to organizational goals Inspires and motivates programming teams to align their work with organizational goals and quality standards.