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 supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
Maintain and manage a project plan including resource forecasting
Coordinate the activities of a global programming team that includes outsource provider staff
Membership on departmental strategic initiative teams
Education Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment
Required Experience and Skills:
Department Required Skills and Experience:
Effective interpersonal skills and ability to negotiate and collaborate effectively
Effective written, oral, and presentation skills
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
Position Specific Required Skills and Experience:
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
Familiarity with clinical data management concepts
Experience in CDISC and ADaM standards
Experience ensuring process compliance and deliverable quality
Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
Ability to anticipate stakeholder requirements
Preferred Experience and Skills:
Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
Ability and interest to work across cultures and geographies
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Experience developing and managing a project plan using Microsoft Project or similar package
Active in professional societies
Experience in process improvement
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.
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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 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.