Lead, Late-Stage Oncology Statistical Programming (Hybrid)

Merck & Co.; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Comprehensive benefits package

Job summary

Merck & Co. in Rahway, NJ is seeking a senior Statistical Programmer to lead programming activities for late-stage drug/vaccine development projects, delivering analysis datasets, tables, listings, and figures across trials and global regulatory submissions.

The role requires extensive SAS experience, CDISC/ADaM proficiency, and ability to guide a global programming team, ensuring timely, high-quality deliverables and collaboration with stakeholders.

Qualifications

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 7 years SAS programming experience in a clinical trial environment
• Effective interpersonal skills and ability to negotiate and collaborate effectively
• Effective written, oral, and presentation skills
• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Leads large and/or complex projects, effectively balances competing priorities, and collaborates closely with key stakeholders to achieve project objectives
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
• Familiarity with clinical data management concepts
• Experience in CDISC and ADaM standards
• US and/or worldwide drug or vaccine regulatory submission experience including the development of electronic submission deliverables
• Experience ensuring process compliance and deliverable quality
• 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
• Ability to anticipate stakeholder requirements
• Experience with GenAI tools (e.g., Python, R, R Shiny, Claude, etc.)
• Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)
• Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
• Ability and interest to work across cultures and geographies
• 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

Responsibilities

• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
• Maintain and manage a project plan including resource forecasting-
• Coordinate the activities of a global programming team that includes outsource provider staff
• Membership on departmental strategic initiative teams

Skills

Base SAS

SAS Programming

Statistical Programming

Clinical Trials

Data Management

CDISC/ADaM

FDA Submissions

Team Leadership

Project Planning

GenAI (Python/R)

Education

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

Tools

SAS/MACRO

SAS/GRAPH

Microsoft Project

Job description

Merck & Co. in Rahway, NJ is seeking a senior Statistical Programmer to lead programming activities for late-stage drug/vaccine development projects, delivering analysis datasets, tables, listings, and figures across trials and global regulatory submissions.

The role requires extensive SAS experience, CDISC/ADaM proficiency, and ability to guide a global programming team, ensuring timely, high-quality deliverables and collaboration with stakeholders.