Job Description

Primary Activities:

• Supports the design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards 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 includes analysis and reporting data standards and submission standards, actively contributing to the department's strategic initiatives.

• Develops and validates global programming standards for ADaM datasets.

• Develops and validates global programming standards for efficacy analysis and reporting using R & SAS.

• Develops and validates global programming standards for safety analysis and reporting using R & SAS.

• Develops and validates global standard utilities using SAS, R & Python.

• Designs and develops complex programming algorithms in SAS, R, R shiny, and its ecosystem, under guidance of staff with extensive expertise in clinical trial A&R standards development.

• Provides technical consultation and analytical support to statistical programmers and statisticians on A&R standard tools.

• Collaborates with key stakeholders, partners in driving development of A&R standard tools following our company standards, processes.

• Collaborates with key stakeholders and partners to provide input on platform and infrastructure from A&R standards perspective.

• Contributes to development and delivery of R & Python training to statistical programmers.

• Provides strategic input for process development for implementation of open source and commercial software in a regulated pharmaceutical development environment under guidance of staff with extensive expertise in clinical trial A&R standards development.

Educational Qualifications:

• Must have a Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 3 years of programming experience that includes minimum 3 years of SAS programming and 1 year of R programming experience in clinical trial environment OR a Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 5 years of programming experience that includes minimum 5 years of SAS programming and 1 year of R programming experience in clinical trial environment.

Position Specific Required Skills and Experience:

• Excellent Knowledge and understanding of CDISC SDTM and ADaM standards including 3 years experience in creating ADaM datasets, ADRG and Define XML for multiple therapeutic areas.

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

• Must possess significant expertise and 1 year experience in applying R for clinical trial programming including generation of figures using ggplot2.

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

• Expertise in applying SAS for clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.

• 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 (analysis datasets, statistical analyses, tables, listings, figures).

• Possess ability to be a project leader; to complete tasks independently at a project level; and to collaborate with key stakeholders.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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/)

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/25/2025

*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: R344149