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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position provides high quality statistical programming analysis and reporting deliverables for modelers in Quantitative Pharmacology and Pharmacometrics spanning all Merck therapeutic areas. The lead programmer will gather and interpret user requirements, retrieve the required data, transform the data into PKPD 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 and is expected to execute project plans efficiently and oversee the work of other team members when opportunities arise.
Key areas of focus may include (1) programmatically synthesizing clinical and preclinical data into analysis ready structures from varied data sources, (2) creating modeling-ready datasets by integrating PK, PD and covariate data, (3) producing tables and graphics for inclusion in study reports and regulatory submissions, (4) ensuring programmatic traceability from data source to modeling result, (5) supporting the development of programming standards to enable efficient and high quality production of programming deliverables, (6) producing SAS transport files and associated documentation for regulatory submissions, (7) representing statistical programming on process improvement activities. Qualifications:
Education Minimum Requirement:
- Bachelor's or Master's Degree (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field.
Required Experience and Skills:
- BA/BS plus 9-12 years or MA/MS plus 7 years SAS programming experience in a clinical trial environment.
- Broad 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).
- Strong project management skills; A project leader; determines appropriate programming methodology, assures programming consistency across protocols, completes programming tasks, and directs the program development effort of other programmers when opportunities arise; ability to engage 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.
Preferred Experience and Skills:
- 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.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com. Search Firm Representatives Please Read Carefully:
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Visa sponsorship is not available for this position.
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