Associate Director – Director, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide technical and operational guidance for statistical programming across clinical studies and development initiatives.

• Ensure the quality, accuracy, timeliness, traceability, and regulatory compliance of programming deliverables.

• Lead the production of SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, exploratory analyses, and responses to regulatory inquiries.

• Offer hands-on leadership in a dynamic biotechnology environment.

• Oversee strategic management of CROs and contractors.

• Collaborate effectively with cross-functional teams.

• Develop scalable standards, automation solutions, and purpose-fit processes.

• Manage clinical programming and regulatory submission activities.

• Support quality assurance, compliance, and readiness for inspections.

• Handle strategic planning and risk management.

• Supervise CROs and vendors.

• Influence cross-functional stakeholders and resolve technical challenges.

• Willingness to travel up to 10–15% based on business needs.

• Provide flexibility during database locks, significant submission milestones, or urgent regulatory responses.

⛳️ Requirements

• Bachelor’s or advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative field.

• Minimum of 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO sectors.

• Proven leadership in studies or programs, experience with BLA/NDA/MAA submissions, vendor management, and functional or personnel leadership.

• Advanced SAS programming expertise, including SAS/BASE, SAS Macro, SAS SQL, ODS, and programming for clinical data analysis and reporting.

• In-depth knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and relevant implementation guidelines.

• Experience in producing and overseeing programming deliverables for clinical study reports and regulatory submissions.

• Familiarity with the clinical drug development process, clinical trial methodologies, statistical principles, GCP, ICH guidance, and electronic submission requirements.

• Proficiency with data and submission validation tools like Pinnacle 21 and resolving validation issues in a documented, risk-based approach.

• Ability to juggle multiple priorities, foresee risks, negotiate realistic timelines, and produce high-quality work in a fast-paced setting.

• Exceptional written and verbal communication skills, sound judgment, attention to detail, and effective influencing abilities in a cross-functional matrix.

• Practical experience with global regulatory submissions, including NDA, BLA, MAA, or equivalent submissions, integrated summaries, information requests, inspections, and post-submission analyses.

• Background in rare diseases, gene therapy, ophthalmology, or other complex clinical development environments.

• Experience with R and relevant clinical development ecosystems; familiarity with Python, XML, Git, or metadata-driven reporting is a plus.

• Experience in creating or managing reusable programming infrastructure, macro libraries, automated QC frameworks, and reproducible reporting workflows.

• Experience in authoring or implementing SOPs, work instructions, programming standards, and vendor governance processes.

• Familiarity with validated cloud or collaborative programming environments and responsible use of AI-assisted programming tools.

• Preference for availability within the US Eastern Standard Time zone.

🏝️ Benefits

• Remote work arrangement.

• Travel up to 10–15% based on business needs.

• Flexibility during database locks, major submission milestones, or urgent regulatory responses.