Senior Scientist, Statistical Programming

Job Description

We are looking for Senior Scientists, Statistical Programming (multiple openings) for our North Wales, PA location to support statistical programming activities for late-stage drug/vaccine clinical development projects for the Biostatistics & Research Decision Sciences (“BARDS”) Department. Accountability includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, table, listing, figures) spanning from individual clinical trials to world-wide regulatory application submissions and post marketing support.

Responsibilities include the following:

• Design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation;

• Serve as 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, serve as statistical programming point of contact and knowledge holder through the entire product lifecycle;

• Perform effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices;

• maintaining and managing a project plan including resource forecasting;

• Coordinating the activities of a global programming team that includes outsource provider staff; and

• Serving on departmental strategic initiative teams.

Education Minimum Requirements:

• MS in Statistics/Biostatistics; pharmacy, public health, or related field and 3 years of SAS programming experience in a clinical trial environment.

• We will also accept a BS and 5 years of SAS statistical programming experience in a clinical trial environment.

Required Experience and Skills:

• Experience must include the following: developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using Oncology Therapeutic Area standards and according to quality, compliance and timeliness requirements

• SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH

• Using statistical analysis methods and clinical data management concepts

• Using SAS in the environment of Unix/Linux; leading projects, including completing programming tasks independently at a project level, following program-wide standards and suggesting/developing additional standards, and engaging key stakeholders

• Working with CDISC standards including SDTM and ADaM as well as their implementations; working with ePRO, RECIST/irRECIST standard in Oncology trials; using CDISC Controlled Terminology

• Generating e-Sub packages for world-wide regulatory submissions such as ISS, ISE, Define and eCRT; using define.xml version 2.0. and Pinnacle 21 to evaluate the compliance in SDTM/ADaM datasets and accompanying data definition documents; and ensuring process compliance and deliverable quality.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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Requisition ID:R131469