*Remote Position*

Associate Director, Statistical Programming

Description
An Associate Director of Statistical Programming provides project leadership / expertise to clinical studies and day-to-day statical 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. 

Please submit your application (resume, cover letter) to HR@DuBuResearch.com