paid / full-time / Lansdale, Pennsylvania, USA
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.
- 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 9-12 years 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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Requisition ID: R55261