Senior Scientist, Statistical Programming, Late-Stage Oncology

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🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $117k - $184.2k / year

⏰ Full Time

🟠 Senior

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• 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