Associate Director, Statistical Programming

About the role

An Associate Director of Statistical Programming provides project leadership / expertise to clinical studies and day-to-day statistical programming activities and is a resource for company initiatives and industry standardization efforts.

Responsibilities

• Leads and supports statistical programming activities for clinical studies, submissions, and development initiatives.
• Contributes to and manages timelines and work product required to deliver high quality statistical programming services.
• Maintains a broad understanding of relevant industry trends in standards implementation and clinical statistical programming.
• Leads in the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics.
• Participates in new business development and bidding processes.
• Collaborates with internal and external stakeholders to facilitate understanding of statistical programming services and product.
• Supports collaboration with Data Management on database standards to facilitate SDTM development.
• Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are validated and meet standards requirements of regulatory agencies, Sponsors, and internal standards.
• Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools.
• Develops innovative programming methodologies to facilitate easier interpretation of clinical trial data by internal and external stakeholders.
• Develops programming efficiencies to ensure a productive work environment producing deliverables of high quality.
• Mentors junior statistical programmers in programming methodologies and relevant company SOPs.
• Programs, validates, maintains, and documents statistical analysis programs for deliverables outlined in the statistical analysis plan or other documents following internal standard operating procedures.

Qualifications

• Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, or related scientific disciplines that provides computer literacy and numeracy, and 8 years of clinical programming experience.
• Expert level SAS programming skills including SQL and macro development.
• Expert level knowledge and application of CDISC standards for SDTM and ADaM.
• A successful history of cross-functional collaboration.
• Sound knowledge of all relevant regulations and guidelines.
• Excellent verbal and written communication skills.
• Excellent planning and organizational skills with the ability to adapt and adjust to changing priorities.
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment.

Remote Position