Senior Scientist, Statistical Programming, Late-Stage Oncology
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Job Description
Senior statistical programmer supporting Merck’s late-stage oncology drug and vaccine development. Delivering SAS-based clinical trial analyses, regulatory submissions, and statistical datasets.
Responsibilities:
- Support statistical programming activities for late-stage drug and vaccine clinical development projects
- Lead one or more projects
- Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures
- Support clinical trials through 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 plans efficiently and deliver high-quality work on time
- Serve as the statistical programming point of contact and knowledge holder through 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 outsourced provider staff
- Participate in departmental strategic initiative teams
- Ensure programming deliverables maintain data integrity and quality after database lock (DBL), including unblinded data
- Address emergent post-DBL challenges through stakeholder communication and technical resolution
Requirements:
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus at least 5 years of SAS programming experience in a clinical trial environment, OR MS in one of these fields plus at least 3 years of such experience
- Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills
- Knowledge and experience developing analysis and reporting deliverables for R&D projects, including data, analyses, tables, graphics, and listings
- Ability to lead projects and complete tasks independently at project level
- 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 understand statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience with CDISC and ADaM standards
- Experience ensuring process compliance and deliverable quality
- Strategic thinking and ability to convert strategy into tactical activities
- Ability to design statistical databases that optimize analysis and reporting and leverage standards and best practices
- Ability to anticipate stakeholder requirements
- Demonstrated proficiency in steering statistical programming deliverables post-DBL and ensuring absolute data integrity of unblinded data
- Strong capability to operate efficiently in high-pressure environments and resolve emergent post-DBL challenges
- Preferred: advanced programming languages such as R, including Shiny, and/or Python
- Preferred: familiarity with Generative AI and emerging technologies in statistical programming pipelines
- Preferred: regulatory application submission experience for US and/or worldwide drug or vaccine products
- Preferred: experience with Microsoft Project or similar project-planning software
- Preferred: professional society activity and process improvement experience
- Ability and interest to work across cultures and geographies
- Ability to complete deliverables using global outsourced programming staff
- Visa sponsorship is available
- No valid driving license required
Benefits:
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
- Medical healthcare
- Dental healthcare
- Vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
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