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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Statistical Programming within Oncology, with a strong focus on CDISC standards, regulatory submissions, and leadership of global programming teams. Proven ability to drive strategic initiatives, implement automation, and foster collaboration across multidisciplinary functions.
Highest-signal resume keywords
Statistical Programming LeadershipCDISC Standards ExpertiseSAS ProgrammingRegulatory Submission ExperienceOncology Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical ProgrammingCDISC StandardsSAS ProgrammingR ProgrammingPython ProgrammingClinical Trial ReportingAutomation ImplementationProcess ImprovementData ScienceQuantitative Analysis
Soft Skills
LeadershipCommunicationStakeholder ManagementOrganizational SkillsCollaboration
Tools & Technologies
Cloud-Based AnalyticsAutomation FrameworksProgramming PlatformsStatistical Software
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryGxP RequirementsRegulatory AffairsClinical DevelopmentNDABLAMAAEmerging AI TechnologiesContinuous Learning
Tech Stack
Tools & technologiesCloudPython
About the role
Key responsibilities & impact- Establish and lead Orion's Statistical Programming function in Oncology
- Provide strategic, operational, and technical leadership within Global Data Sciences
- Build and lead a high-performing global programming organization
- Define the Statistical Programming strategy, operating model, standards, and capabilities
- Partner with Biostatistics, Clinical Data Management, Clinical Development, Regulatory Affairs, Medical Writing, and external partners
- Lead organizational design, talent strategy, workforce planning, and capability development
- Oversee programming activities across clinical studies and programs
- Ensure delivery of SDTM, ADaM, TLFs, define.xml, reviewer guides, and other submission-related deliverables
- Monitor resource utilization, capacity, risks, timelines, and quality metrics
- Provide programming leadership for development milestones, regulatory interactions, and health authority submissions
- Own and evolve programming standards, processes, templates, conventions, and best practices
- Ensure compliance with CDISC standards, global regulatory requirements, GxP expectations, and company procedures
- Lead preparation and support for regulatory inspections and audits
- Establish technology strategy, including programming platforms, standards repositories, automation frameworks, and development tools
- Drive adoption of modern technologies, automation, and AI-enabled workflows
- Evaluate and implement emerging programming methodologies, tools, and industry best practices
- Recruit, develop, mentor, and retain statistical programming talent
- Foster accountability, collaboration, innovation, continuous learning, and positive engagement
- Provide coaching and professional development opportunities
- Promote collaboration across Biostatistics, Clinical Data Management, Clinical Operations, and other functions
Requirements
What you’ll need- Master's degree or equivalent in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline
- 15+ years of statistical programming experience within the pharmaceutical or biotechnology industry, with oncology experience preferred
- Significant leadership experience managing Statistical Programming organizations and global programming teams
- Track record of leading programming support for global regulatory submissions, including NDA, BLA, MAA, or equivalent filings
- Deep expertise in CDISC standards, including SDTM, ADaM, define.xml, controlled terminology, and submission requirements
- Strong knowledge of SAS programming and clinical trial reporting methodologies
- Experience with R, Python, cloud-based analytics environments, or other modern programming technologies
- Demonstrated success implementing standards, automation, process improvements, and scalable operating models
- Strong understanding of clinical development, regulatory expectations, and GxP requirements
- Interest in emerging AI technologies and their practical application to statistical programming and drug development
- Excellent leadership, communication, stakeholder management, and organizational skills
- Ability to influence across functions, lead through change, and drive strategic initiatives in a global environment
- Approved medical examination including drug testing required prior to employment
- Security clearance required prior to employment
Benefits
Comp & perks- Competitive incentive opportunities
- Comprehensive benefits package
- Career paths and development opportunities
- Professional development opportunities
- Culture of friendliness, respect, mutual appreciation, and diversity
- Safe working environment
- Approved medical examination and drug testing prior to employment
- Security clearance prior to employment