AD Statistical Programming

Our client is looking for an AD Statistical Programming to lead programming activities for clinical trials. This role involves hands-on statistical analysis using SAS/R, quality review of deliverables, and collaboration with Biostatistics and Clinical Data Management to ensure high-quality data. The AD will also contribute to SOP development, programming standards, and the Statistical Computing Environment (SCE) platform.

Key Responsibilities

• Lead programming efforts for clinical trials, ensuring timely and high-quality deliverables.
• Oversee the development and validation of SDTM, ADaM, and TLFs for regulatory submissions, publications, and ad-hoc analyses.
• Review SAPs, Data Presentation Plans, and Table Shells to ensure alignment with study objectives.
• Manage CROs and contractors, ensuring compliance with timelines, quality standards, and budgets.
• Collaborate with Biostatistics, Data Management, and Clinical teams to support study design and data accuracy.
• Develop global programming tools (e.g., macros, automation) to optimize efficiency.
• Assist in building the SCE platform, including structuring and access control.

Leadership & Strategy

• Implement innovative programming strategies and technologies.
• Establish and maintain programming standards and best practices.
• Identify risks and develop mitigation strategies to enhance programming capabilities.
• Mentor and manage junior programmers, providing guidance and performance feedback.
• Support hiring and team expansion efforts.

Qualifications

• Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• 8+ years of statistical programming experience in pharma, biotech, or CRO environments.
• Expertise in SAS programming, CDISC standards (SDTM, ADaM), and regulatory submissions.
• Strong understanding of drug development, statistical methodologies, and regulatory guidelines.
• Experience managing outsourced programming activities.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
• Regulatory audit experience (FDA, EMA, etc.) is a plus.