Job Description

This position 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's standards, processes

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus minimum of 9 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 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/packages

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

• 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 andXML 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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Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

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 employees 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 .

You can apply for this role through (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:

Relocation:

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*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.