Senior Programmer, Quantitative Pharmacology and Pharmacometrics Job - United States
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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 125-year legacy. 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.
This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all Merck therapeutic areas from phase I to phase III. This position will also support Clinical Pharmacology Statisticians. The senior programmer will gather and interpret user requirements, retrieve the required data, transform the data into modeling-ready analysis datasets, and develop tables and figures according to the modeling analysis plans. The programmer will take on a data stewardship leadership role and be accountable for the creation of modeling data from original data source(s) to final modeling dataset. The programmer will be a key collaborator with modelers, statisticians and other project stakeholders.
Key areas of focus may include (1) creating modeling-ready datasets by integrating PK, PD and covariate data, (2) creating ADaM datasets to support analysis and reporting needs, (3) producing tables and graphics for inclusion in study reports and regulatory submissions, (4) ensuring programmatic traceability from data source to analysis/modeling result, (5) supporting the development of programming standards to enable efficient and high quality production of programming deliverables, (6) preparing ADaM package for regulatory submissions.
- Required: Bachelors Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering with a minimum of 5 years of SAS programming experience in a clinical trial environment
- Preferred: Master's Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering with a minimum of 3 years of SAS programming experience in a clinical trial environment
- Knowledge and experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) for research and development projects
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; Graphics experience; systems and database experience
- Designs and develops complex programming algorithms
- Ability to comprehend analysis plans which may describe methodology to be programmed; Understanding of statistical or pharmacokinetic terminology and concepts; Implements statistical methods not currently available through commercial software packages.
- 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 clinical trial datasets including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
- A project leader; completes programming tasks independently at a project level; ability to collaborate with key stakeholders
- Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; seamlessly assimilates to new projects and stakeholders; an experienced programming mentor
- Familiarity with pharmacokinetics modeling and simulation datasets and analyses
- Experience with at least one other software than SAS (e.g., R, Splus, NonMem)
- Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Utilizes and contributes to the development of standard departmental SAS macros
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 an accommodation for the application process please email us at email@example.com.
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Job: Statistical Programming
Job Title:Sr. Scientist, Stat. Programming
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Medical, Pharmacology, Quantitative Analyst, Developer, Engineer, Healthcare, Data, Technology, Engineering