ADS Lead

About the Role

Key Responsibilities

• Oversee programming and analytical strategy across multiple molecules or an entire disease area, ensuring alignment with clinical, regulatory, and enterprise data goals.
• Lead cross-functional planning and execution of data deliverables, ensuring quality, consistency, and timeliness across programs, accountable to the TA leads.
• Represent the data science function in high-level internal forums and global regulatory engagements, contributing to regulatory strategy.
• Resolve complex technical and operational challenges impacting delivery, quality, or external perception.
• Drive adoption of innovative programming tools, scalable delivery models, and automation approaches to improve performance and sustainability.
• Manage vendor oversight and coordination of external partners to ensure high-quality, efficient, and aligned delivery.
• Shape the broader Product Development Data Science agenda through governance, strategic planning, and enterprise initiatives.
• Manage a team of ADS Programmers, including workload allocation, performance management, and development planning.
• Build and sustain a high-performing team by identifying skill gaps, hiring talent, and fostering a culture of excellence, innovation, and collaboration.
• Guide the team through ambiguity, providing direction and support for complex projects and shifting priorities.
• Ensure portfolio deliverables such as submissions, outputs, and applications meet expectations for quality, compliance, and timelines.

Requirements

• Hold an advanced degree (Master's or PhD) in Statistics, Biostatistics, Computer Science, Life Sciences, or a related quantitative field.
• Have 12+ years of experience in statistical and analytical programming within clinical development, with demonstrated impact across multiple programs or therapeutic areas.
• Deep expertise in clinical trial data standards (e.g., CDISC SDTM and ADaM), regulatory submission requirements, and end-to-end data workflows.
• Proficiency in programming languages and tools such as SAS, R, Python, with experience implementing scalable, reusable, and automated solutions.
• Strong understanding of global regulatory expectations and experience representing programming in interactions with health authorities.
• Ability to lead large-scale initiatives and resolve complex technical challenges with minimal guidance.
• Experience contributing to functional innovation, including adopting new tools, standards, or delivery models.
• Respect for cultural differences when interacting with colleagues in the global workplace.

Nice to Have

• Experience leading programming strategy for global regulatory submissions, including integrated summaries (ISS/ISE).
• Familiarity with metadata-driven programming approaches or enterprise-level data standardization.
• Proven ability to drive functional innovation through automation, process improvement, or emerging tools.
• Exposure to real-world data or digital health integration within clinical development.
• Participation in industry working groups, consortia, or recognized contributions to advancing programming standards or practices.

Qualifications

• Advanced degree (Master's or PhD) in a relevant quantitative field.

Benefits & Perks

• Expected salary range of $152,300.00 - $282,800.00 based on location and experience.
• Discretionary annual bonus based on individual and company performance.
• Benefits detailed at the provided link.