Sr. Scientist Stat Programming, Late-Stage Development (Hybrid)

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.

Responsibilities:

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 incumbent 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 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

Required Experience and Skills:

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

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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 Experience and Skills:

Experience using R for statistical modeling, data analysis, and visualization

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

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Required Skills:

CDISC ADaM, Clinical Data Interchange Standards Consortium (CDISC) Standards, Clinical Development, Computer Science, Database Management Systems (DBMS), Data Management, Data Modeling, Leadership, Numerical Analysis, Outcomes Research, Process Improvement Projects, Project Management, Project Planning, Software Development, Stakeholder Relationship Management, Statistical Analysis, Statistical Analysis Systems (SAS) Programming, Statistical Programming, Waterfall Model

Preferred Skills:

Regulatory Submissions, R Programming

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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 if you need an accommodation during the application or hiring process.

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.

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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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

06/24/2026*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: R399884