Merck Senior Scientist, Statistical Programming in Rahway, New Jersey

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Responsibilities:

This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics. The senior statistical programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with statistical and clinical colleagues, retrieve the required data, and then transform the data into analysis datasets for further statistical analysis and reporting needs. The senior programmer will partner with statisticians to solve problems; reduce the amount of programming task being completed by statisticians to facilitate an increase in efficiency and compliance for statistical analyses. The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages.

Primary Activities:

  • Pre - process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data

  • Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses

  • Prepare compliant programming code for regulatory submissions including analysis datasets, tables, listings, figures and associated documentation

  • Support the development of programming standards to enable efficient and high quality production of programming deliverables

  • Create specifications for ADaM (analysis) datasets

  • Review study deliverables to ensure that they are in compliant with company standards and SOPs

  • Create electronic submission ready deliverables

Education Minimum Requirement:

  • B.A. / B.S. in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 - 9 years SAS / R programming experience in a clinical trial environment

  • M.S. in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 - 7 years SAS / R programming experience in a clinical trial environment

Required Experience and Skills:

  • Excellent interpersonal skills and ability to negotiate and collaborate effectively

  • Excellent written, oral, and presentation skills

  • Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings)

  • A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

  • Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS / MACRO, SAS / GRAPH

  • Designs and develops complex programming algorithms

  • Experience in CDISC SDTM and ADaM standards

  • 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.

  • Thrives in an exploratory environment, handling non - standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

  • Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

  • Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation

Preferred Experience and Skills:

  • Familiarity with clinical pharmacology concepts

  • Oncology programming experience

  • Good working knowledge of reporting processes (SOPs) and software development life - cycle (SDLC)

  • Utilizes and contributes to the development of standard departmental SAS macros

  • Ability and interest to work across cultures and geographies

  • Ability to complete statistical programming deliverables through the use of global outsource partner programming staff

  • Active in professional societies

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Statistical Programming

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Senior Scientist, Statistical Programming

Primary Location: NA-US-NJ-Rahway

Requisition ID: STA000919