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.

Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials. 

The Associate Principal Scientist, Statistical Programmer 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 and actively contributes to the department's strategic initiatives.

Primary Activities:

Develop and validate global programming standards for ADaM datasets

Develop and validate global programming standards for efficacy analysis and reporting

Develop and validate global programming standards for safety analysis and reporting

Design and develop complex programming algorithms

Provide technical consultation and analytical support to statistical programmers and statisticians

Represent our Company on relevant industry initiatives including R Consortium, TransCelerate, PHUSE, CDISC,. 

Collaborate with key stakeholders, partners in driving Analysis & Reporting standard programs using our Company standards, processes

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 or more years of SAS programming experience in a clinical trial environment

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years of SAS 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

Broad knowledge and significant experience in developing analysis and reporting deliverables for Research & Development (R&D) projects (data, analyses, tables, listings, figures)

Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills and Experience:

Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and familiarity with at least one other statistical computing software

Knowledge and understanding of CDISC SDTM and ADaM 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

Preferred Skills and Experience:

Experience in developing flexible and efficient complex analysis and reporting standard SAS macros

R, Python and  XML experience

Experience with Linked data, natural language processing

Experience using SAS, R in Unix/Linux environment

Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages

Ability and interest to work across cultures and geographies

Active in professional societies

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R320748