Director, Statistical Programming
Scorpion Therapeutics, Raleigh, North Carolina, United States, 27601
Role Summary
Director, Statistical Programming – SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of statistical programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role manages a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, partnering with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services. Responsibilities
Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions. Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team. Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs). Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness. Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization. Manage project timelines, budgets, and external vendor relationships as needed. Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity. Represent the statistical programming function in cross-functional meetings and strategic initiatives. Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality. Evaluate and integrate emerging technologies into statistical programming workflows. Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables. Oversee code quality, version control, and documentation governance frameworks. Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders. Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables. Qualifications
Required: PhD / PharmD and 8 years of experience; OR Master’s and 10 years of experience; OR Bachelor’s and 12 years of experience. Preferred: Education in Biostatistics, Computer Science, or related field; advanced degree preferred. Skills
Expert in SAS Macros; strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud. Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering. Education
BS/MS/PhD in Biostatistics, Computer Science, or related field (advanced degree preferred).
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Director, Statistical Programming – SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of statistical programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role manages a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, partnering with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services. Responsibilities
Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions. Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team. Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs). Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness. Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization. Manage project timelines, budgets, and external vendor relationships as needed. Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity. Represent the statistical programming function in cross-functional meetings and strategic initiatives. Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality. Evaluate and integrate emerging technologies into statistical programming workflows. Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables. Oversee code quality, version control, and documentation governance frameworks. Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders. Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables. Qualifications
Required: PhD / PharmD and 8 years of experience; OR Master’s and 10 years of experience; OR Bachelor’s and 12 years of experience. Preferred: Education in Biostatistics, Computer Science, or related field; advanced degree preferred. Skills
Expert in SAS Macros; strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud. Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering. Education
BS/MS/PhD in Biostatistics, Computer Science, or related field (advanced degree preferred).
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