Assoc. Principal Scientist Stat. Programming - Late-Stage, Infectious Disease (Hybrid)

Job Description 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 The assurance of deliverable quality and process compliance. Effective deliverable development utilizing global and therapeutic area standards that optimize analysis and reporting and promote a strategic knowledge‑base data model. Maintaining and managing a project plan including resource forecasting. Coordinating the activities of a global programming team that includes outsource provider staff. Membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development. Education and Minimum Requirements BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus 9 years of 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 of SAS programming experience in a clinical trial environment. Required Skills and Experience Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team. Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and therapeutic area standards and according to quality, compliance and timeliness requirements. 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. 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. 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. 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‑practice. Experience in CDISC and ADaM standards. Demonstrated success in the assurance of deliverable quality and process compliance. Ability to anticipate stakeholder and regulatory requirements. Preferred Experience and Skills Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC). Ability and interest to work across cultures and geographies. Experience providing technical and/or programming guidance and mentoring to colleagues. Ability to complete statistical programming deliverables through the use of global outsource partner programming staff. Experience developing and managing a project plan using Microsoft Project or similar package. Active in professional societies. Experience in process improvement. US and Puerto Rico residents only: we will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance and other applicable local laws. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. Compensation Salary range: $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The 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. Benefits We offer a comprehensive package of benefits including medical, dental, vision, healthcare, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at Logistics Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/3/2026. The application deadline is stated on this posting. The job posting is effective until 11:59:59 PM on the day before the job posting end date. #J-18808-Ljbffr Merck & Co.