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George Mason University
Job Opportunity

Sr. Statistical Programmer, Late Stage Development Oncology at Merck & Co., Inc.

Full Job Details

Employer: Merck & Co., Inc. - Research Laboratories

Expires: 05/01/2026

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities:This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities:Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practicesMaintain and manage a project plan including resource forecasting Coordinate the activities of a global programming team that includes outsource provider staffMembership on departmental strategic initiative teams Skills:Education and Minimum Requirement:BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment Department Required Skills and Experience:Effective interpersonal skills and ability to negotiate and collaborate effectivelyEffective written, oral, and presentation skillsEffective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders Position Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertiseDesigns and develops complex programming algorithmsAbility to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable qualityStrategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practicesAbility to anticipate stakeholder requirements Preferred Skills and Experience:Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentorAbility and interest to work across cultures and geographiesAbility to complete statistical programming deliverables through the use of global outsource partner programming staffExperience developing and managing a project plan using Microsoft Project or similar packageActive in professional societiesExperience in process improvement

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