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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 the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas. Adheres to standard operating procedures and guidelines established by the department. Drives data structures which include analysis and reporting data standards and submission standards. Actively leads and contributes to the department's strategic initiatives.

The position is a key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.

Primary Activities:

• Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.

• Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.

• Facilitate global adoption of standards and programming best practices.

• Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our Research & Development Division.

• Provide technical consultation and analytical support to statistical programmers and statisticians.

• Lead and actively contribute to departmental strategic initiative project teams.

• Represent our Company on relevant industry initiatives including CDISC and PHUSE.

Skills:

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 or more years statistical programming experience in a clinical trial environment OR

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years statistical programming experience in a clinical trial environment

Department Required Skills and Experience:

• Excellent interpersonal skills and ability to negotiate and collaborate effectively.

• Excellent written, oral, and presentation skills.

• Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).

• Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

Position Specific Required Skills and Experience:

• Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools.

• Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements.

• Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.

  Experience working with analytical research databases including various analysis datasets and procedures.

• Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.

• Demonstrated success in the assurance of deliverable quality and process compliance.

• Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions.

• Ability to anticipate stakeholder requirements.

• Ability and interest to work across cultures and geographies.

Preferred Skills and Experience:

• Experience developing flexible and efficient multilingual products for analysis and reporting using R, Python, SAS.

• Experience with process assessment, improvement and operational excellence methodologies.

• Experience developing and managing project plans.

• Experience using AI/GenAI tools, such as Claude Code, to enhance coding, automation, and workflow efficiency.

• Active in professional societies and ability to collaborate across regions.

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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:

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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

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.

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