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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in SAS programming for clinical trials, including the development of analysis and reporting deliverables, while effectively collaborating with stakeholders to ensure high-quality project execution. Possesses strong strategic thinking abilities and a comprehensive understanding of regulatory submission processes.
Highest-signal resume keywords
SAS ProgrammingClinical Trial ProgrammingCDISC and ADaM StandardsStatistical Analysis and ReportingProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SASStatistical AnalysisData StepsSAS/MACROSAS/GRAPHProgramming AlgorithmsStatistical TerminologyAnalysis PlansClinical Data ManagementResource Forecasting
Soft Skills
Interpersonal SkillsNegotiation SkillsCollaboration SkillsWritten CommunicationPresentation Skills
Tools & Technologies
Statistical SoftwareDatabase Systems
Industry Keywords
Clinical DevelopmentRegulatory SubmissionsDrug DevelopmentVaccine DevelopmentOutcomes Research
About the role
Key responsibilities & impact- Lead statistical programming activities for multiple and/or large/complex late-stage drug and vaccine clinical development projects
- Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures
- Support clinical trials, worldwide regulatory application submissions, and post-marketing activities
- Design and maintain statistical datasets for clinical development, outcomes research, and safety evaluation stakeholders
- Collaborate with statistics and project stakeholders to execute project plans efficiently and deliver high-quality work on time
- Serve as the statistical programming point of contact and knowledge holder throughout the product lifecycle
- Develop and validate analysis and report programming using global and therapeutic-area standards, departmental SOPs, and good programming practices
- Maintain and manage project plans, including resource forecasting
- Coordinate a global programming team, including outsource provider staff
- Participate in departmental strategic initiative teams
Requirements
What you’ll need- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 years SAS programming experience in a clinical trial environment, OR MS in one of these fields plus a minimum of 7 years SAS programming experience in a clinical trial environment
- Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills
- Knowledge and experience developing analysis and reporting deliverables for R&D projects
- Experience leading large and/or complex projects and balancing competing priorities
- Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, and SAS/GRAPH
- Systems and database expertise
- Ability to design and develop complex programming algorithms
- Ability to comprehend analysis plans and understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience in CDISC and ADaM standards
- US and/or worldwide drug or vaccine regulatory application submission experience, including electronic submission deliverables
- Experience ensuring process compliance and deliverable quality
- Strategic thinking and ability to turn strategy into tactical activities
- Ability to anticipate stakeholder requirements
- Willingness and ability to work across cultures and geographies
- 10% travel requirement
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Visa sponsorship
- Hybrid work arrangement
