Senior Scientist Statistical Programming, Late-Stage (Hybrid)

Merck; North Wales (Montgomery County); Híbrido; USD 117.000 - 184.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) retirement

Paid holidays

Vacation

Sick days

Descripción de la vacante

Merck & Co., Inc. in Rahway, NJ, invites qualified statistical programmers to join BARDS, a pivotal part of R&D.

The role focuses on leading statistical programming activities for late-stage clinical development, delivering safety and efficacy analysis datasets, tables, listings, and figures for global submissions and post-marketing support. You will design and maintain analysis datasets, coordinate a global programming team, ensure quality and compliance with CDISC ADaM standards, and

Formación

• Experience in statistical programming for clinical trials.
• Understanding of analysis and reporting deliverables for R&D projects.
• Ability to collaborate with key stakeholders and lead tasks.

Responsabilidades

• Lead statistical programming activities for late-stage clinical development.
• Develop and validate analysis datasets, tables, listings, and figures.
• Coordinate global programming team including outsource staff.
• Maintain project plans and ensure timely, high-quality deliverables.

Conocimientos

CDISC ADaM

CDISC Standards

Clinical SAS Programming

Clinical Trials

Data Management

Data Modeling

Macro Programming

Numerical Analysis

Stakeholder Management

Waterfall Model

Educación

BA/BS in Computer Science, Statistics, or related

MS in Computer Science, Statistics, or related

Herramientas

SAS

SAS MACRO

SAS GRAPH

Descripción del empleo

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 supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more 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.

Education and Minimum Requirement

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 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 3 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).
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders.

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.
• 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 R, R Shiny, R Force, Python Claude etc) is highly preferred.
• Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
• US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
• 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.

Required Skills

CDISC ADaM, Clinical Data Interchange Standards Consortium (CDISC) Standards, Clinical SAS Programming, Clinical Trials, Data Management, Data Modeling, Macro Programming, Numerical Analysis, Stakeholder Relationship Management, Waterfall Model

Preferred Skills

Python (Programming Language), Regulatory Submissions, R Programming

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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

10/23/2026

• 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.

The salary range for this role is $117,000.00 - $184,200.00

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.

The application deadline for this position is stated on this posting.