Associate Principal Scientist, Statistical Programming, Late-Stage Oncology (Hybrid)

Merck; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a seasoned Statistical Programming Lead to drive late-stage drug/vaccine programs. You will develop analysis datasets, tables, listings, and figures, coordinating global teams and external outsource staff.

Requires 9+ years SAS programming in clinical trials (BA/BS) or 7+ years (MS). Strong collaboration, governance, and SDLC adherence are essential for successful regulatory submissions.

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

Responsibilities

• Lead statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.
• Develop and execute statistical analysis and reporting deliverables (datasets, tables, listings, figures).
• Design and maintain statistical datasets supporting multiple stakeholder groups.
• Collaborate with statistics and project stakeholders to ensure timely, high-quality deliverables.

Skills

Base SAS

SAS programming

Data management

FDA Submissions

Project management

Stakeholder management

Statistical programming

Clinical trials

Quality assurance

SAS macro

SAS/GRAPH

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

SAS Macro

SAS/GRAPH

Clinical Data Systems

Job description

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.

Primary Activities:

• 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

Education and Minimum Requirement:

• 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

Department Required Skills and Experience:

• 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

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 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

Preferred Skills and Experience:

• 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

eligibleforERP

SPjobs

VETJOBS

EBRG

Required Skills:

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

Preferred Skills:

Artificial Intelligence (AI), Generative AI, Python (Programming Language), R Programming

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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:

10/10/2026

***A job posting is effective until 11:59:59PM on the day** BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R416087