Merck & Co., Inc
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 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
We are looking for a Senior Scientists, Statistical Programming (multiple) for our North Wales, PA location to be responsible for supporting 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, tables, listing, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Responsibilities include the following:
The 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.
Serve as statistical programming point of contact and knowledge holder through the entire product lifecycle on assigned projects, including: (1) performing effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices; (2) maintaining and managing a project plan including resource forecasting; (3) coordinating the activities of a global programming team that includes outsource provider staff; and (4) membership on departmental strategic initiative project teams.
MS in Statistics, Applied Mathematics, Clinical Research Administration, or related field.
3 years of SAS programming experience in a clinical trial environment, including the following: generating reports and necessary analysis required for NDA and FDA submissions; developing analysis and reporting deliverables (data, analyses, tables, graphs, listings); SAS/MACRO, SAS/GRAPH; performing validation and QA; ensuring outputs adhere to specifications and validation plans; performing review and evaluation of clinical research related programs; and performing study analysis and report generation according to client requirements.
We will also accept a BS and 5 years of experience.
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 email@example.com.
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Merck & Co., Inc
Website : http://www.merck.com
Merck has a long and rich history of working to improve people's health and well-being. Through the years, our researchers have helped to find new ways to treat and prevent illness - from the discovery of vitamin B1, to the first measles vaccine, to cold remedies and antacids, to the first statins to treat high cholesterol. Our scientists also have helped develop many products to improve animal health, including vaccines and antibiotics. While we are proud of our past, we are enthusiastic about the future of this new company and we are excited to help create a healthier, brighter future for people around the world.