Associate Principal Scientist, Statistical Programming, Late-Stage Oncology (Hybrid)
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. in the BARDS department seeks a senior statistical programming lead to manage SAS programming activities for late-stage drug/vaccine projects. You will develop and execute analysis datasets, tables, listings, and figures across trials and global submissions.
You will design and maintain statistical datasets, collaborate with statistics and other stakeholders, and ensure high-quality deliverables within regulatory timelines. Remote/hybrid options may apply.
Qualifications
- Strong SAS programming experience in clinical trials and regulatory submissions.
- Excellent interpersonal and communication skills for cross-functional collaboration.
- Ability to lead large, complex projects and balance competing priorities.
Responsibilities
- Effective analysis and report programming development and validation utilizing global and TA standards.
- 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
Education
Tools
Job description
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.
This position leads the 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 incumbant 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.
- 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
- 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 application 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
BARDS2020
Base SAS, Clinical Development, Data Management, Data Modeling, FDA Submissions, Influencing Skills, Oncology, Presentation Delivery, Process Improvements, Project Management, Project Planning, Resource Planning, Stakeholder Management, Statistical Programming, Strategic Planning, Strategic Thinking
Artificial Intelligence (AI), Generative AI, Python (Programming Language), R Programming
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
The salary range for this role is $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. 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 .
San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Regular
Domestic
Yes
10%
Hybrid
Not Indicated
No
n/a
10/10/2026
R416087
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