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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 and Regulatory Submissions, with a strong focus on SAS programming, cross-functional collaboration, and process improvement. Proven leadership in managing teams and driving strategic initiatives within the pharmaceutical industry.
Highest-signal resume keywords
Statistical ProgrammingSAS Base ProgrammingRegulatory SubmissionsLeadership SkillsProcess Improvement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SAS STATSAS GRAPHSAS MACROStatistical AnalysisData ScienceOperational StrategySubmission PlanningProgramming StandardsClinical Trial ExperienceResource Management
Soft Skills
Communication SkillsTeam LeadershipInfluencing SkillsCoaching SkillsCollaboration
Certifications & Qualifications
Bachelor's DegreeMaster's DegreePhD in Statistics or Mathematics
Industry Keywords
Global Regulatory SubmissionsComplianceClinical TrialsCross-Functional TeamsChange Management
About the role
Key responsibilities & impact- Head the Global Submissions group within Statistical Programming, Digital and Data Science
- Oversee strategy, planning, and execution of global regulatory submissions across the portfolio
- Allocate resources to meet program and therapeutic area submission milestones
- Partner across departments to align strategies
- Maintain high-quality standards
- Shape operational strategies for submission-related statistical programming activities
- Strengthen cross-functional partnerships and improve internal processes
- Support drug programs and advance development sciences through best practices and innovation
- Coach, influence, and advocate for the team
- Develop and implement operational and sourcing strategies for global submissions
- Develop and influence global submission planning and timelines
- Ensure timely execution of statistical programming and electronic submission activities across drug programs
- Identify technical and process improvement opportunities and drive implementation
- Develop and oversee programming standards, conventions, and efficient procedures
- Provide leadership in talent acquisition, retention, and development
- Collaborate with cross-functional teams to align strategies and ensure optimal data delivery and analysis
- Manage resources and budgets effectively
- Stay updated on regulatory requirements and trends to ensure compliance
- Promote innovation and continuous improvement within the team
Requirements
What you’ll need- Bachelor’s degree required; Masters or PhD in Statistics or Mathematics preferred
- 12+ years of relevant work experience in Statistical programming and analysis
- 12+ years of SAS Base programming experience
- 7+ years using SAS STAT, GRAPH, and MACRO
- 12+ years of relevant industry experience and clinical trial experience
- 7+ years in a supervisory (Managerial) role
- Extensive hands-on experience working on and leading global regulatory submissions from sponsor side
- Extensive and up to date knowledge of regulatory requirements and global submission guidelines
- Strong management and leadership skills with the ability to lead cross-functional teams
- Proven ability to manage multiple priorities and drive process improvements
- Excellent written and oral communication skills
- Preferred: experience with strategic change management within a large cross-functional initiative
- Preferred: strong skills in compelling communication, driving execution, and cultivating networks
Benefits
Comp & perks- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation
- End-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays
- 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities
- Learning, growth, and expanding skills opportunities
