Associate Principal Programmer, Statistical Programming- Oncology
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.
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.
The Associate Principal Programmer, Clinical Trial Analysis and Reporting leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis data sets, 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 databases 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.
Key areas of focus include:
(1) The assurance of deliverable quality and process compliance,
(2) Effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model,
(3) Maintaining and managing a project plan including resource forecasting,
(4) Coordinating the activities of a global programming team that includes outsource provider staff.
(5) Membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.
Education Minimum Requirement:
- Bachelor's or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering
Required Experience and Skills:
Preferred Experience and Skills:
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Ability and interest to work across cultures and geographies.
- Experience providing technical and/or programming guidance and mentoring to colleagues
- 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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Job: Statistical Programming
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name: Merck