Merck - Associate Principal Statistical Programmer

paid / Upper Gwynedd, PA - Rahway, NJ / full-time

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

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.

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 Responsibilities:

  • 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 in R, R shiny, and its ecosystem.
  • Provide technical consultation and analytical support to statistical programmers and statisticians in R, R shiny, and its ecosystem.
  • Represent our Company on relevant industry initiatives including R Consortium, TransCelerate, PHUSE, CDISC.
  • Serve as Statistical Programming Subject Matter Expert for R programming, package and Shiny app development.
  • Partner with key stakeholders, partners in driving R packages and Shiny app development following our Company's standards, processes.
  • Partner with key stakeholders and partners to provide input on R platform and infrastructure.
  • Contribute to development and delivery of R training to statistical programmers.
  • Provide strategic input by bridging R and SAS knowledge within statistical programming organization to meet stakeholder needs.
  • Provide strategic input for documentation process development for implementation of open source software in a regulated pharmaceutical development environment.

Education Minimum Requirements:

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 or moreyears of programming experience in a clinical trial environment including substantial experience in R and experience in SAS.
  • MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years of programming experience in a clinical trial environment including substantial experience in R and experience in SAS.

Required Experience and Skills:

  • Excellent interpersonal skills and ability to negotiate and collaborate effectively.
  • Excellent written, oral, and presentation skills.
  • Developing analysis and reporting deliverables for Research & Development 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.
  • Significant expertise in applying R for clinical trial programming including R package and R Shiny app development.
  • Knowledge and understanding of Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (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.
  • Expertise in applying SAS for clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.

Preferred Experience and Skills:

  • RStudio Server Pro, RStudio Connect and RStudio Package Manager.
  • Repository Manager Tools (e.g., Artifactory).
  • Expertise in version control tools (e.g., git, github, bitbucket), Ci/CD tools (e.g., Jenkins, Travis CI, github action), docker container.
  • Developing flexible and efficient complex analysis and reporting standard SAS macros.
  • Python and XML.
  • Linked data, natural language processing.
  • 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.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

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 if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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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