In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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

• This position supports statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development 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 databases 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

Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders

• Strategic 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-practices

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team
• Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
• Familiarity with statistical analysis methods and clinical data management concepts
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
• Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms
• Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders
• Experience in CDISC and ADaM standards
• Demonstrated success in the assurance of deliverable quality and process compliance

Ability to anticipate stakeholder and regulatory requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment

Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements Accountability, Clinical Development, Computer Science, Data Management, Data Modeling, Innovation, Machine Learning (ML), Microsoft Project, Numerical Analysis, Outcomes Research, Pharmaceuticals Marketing, Process Improvements, REMOTE_SKILL-1-52891, Resource Forecasting, Software Development, Stakeholder Engagement, Stakeholder Relationship Management, Statistical Analysis, Statistical Programming, Waterfall Model

$142,400.00 - $224,100.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits