Associate Principal Scientist-Clinical Safety Statistics (CSS) Job

Rahway, NJ, US
September 08 2017
Organization Type
Associate Principal Scientist-Clinical Safety Statistics (CSS)-STA000863


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 Scientist, Clinical Safety Statistics (CSS), leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine projects in support of the Clinical Safety and Risk Management (CSRM) center of excellence in the Biostatistics organization.

Primary accountabilities include: (1) the building of analytical safety databases to enable ongoing aggregate review and cumulative meta-analysis of safety (2) the development and execution of the analysis and reporting process according to the program safety analysis plan including the generation of tables, listings and figures to support statistical evaluations and safety review.

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.

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. (5) membership on departmental strategic initiative project teams.   


Education Requirement:

- Bachelor's Degree

- Master's Degree or equivalent preferred in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering

Required Experience:

- Bachelor’s with a minimum of 9 years or Master’s with a minimum of 7 years SAS programming experience in a clinical trial environment

- Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team

- Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements.

- Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.

- Familiarity with statistical analysis methods and clinical data management concepts.

- Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders

- Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms;

- Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders.

- St 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

Preferred Experience:

- Experience developing and implementing statistical programming standards and tools that enable efficient aggregate safety evaluation

- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

- Ability and interest to work across cultures and geographies.

- Providing technical and/or programming guidance and mentoring to colleagues

- 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.

If you need an accommodation for the application process please email us at

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Job: Statistical Programming

Job Title:Assoc Prin.Scientist Stat.Programming

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-Upper Gwynedd

Employee Status: Regular

Number of Openings: 3

Shift (if applicable): 1st

Company Trade Name:Merck

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