Merck Senior Statistical Programmer in Rahway, New Jersey
Our Quantitative Sciences team uses big data to investigate the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical study of decision-making in clinical trials. Accountability predominantly includes the development and execution of statistical study and reporting deliverables (e.g. safety and efficacy study of datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions. The incumbent is responsible for the design and maintenance of statistical datasets that Support multiple stakeholder groups.
This position supports statistical programming activities for Early Oncology 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), Pharmacokinetics Pharmacodynamics (PKPD) deliverables for early oncology studies. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, and safety evaluation.
Effective analysis and report programming development and validation, utilizing global and therapeutic area standards and following departmental standard operating procedures (SOPs) and good programming practice.
Maintain and manage a project plan including resource forecasting.
Coordinate the activities of a global programming team that includes outsourcing provider staff.
BA/BS preferably in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 years of SAS/R programming experience in a clinical trial environment
MS, preferably in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years of SAS/R programming experience in a clinical trial environment
Required Skills and Experience:
Oncology programming experience
Designs and develops complex programming algorithms
Experience in Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and ADaM standards
Ability to comprehend analysis plans which may describe the methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Excellent communication (oral, written) skills, interpersonal skills and ability to negotiate and collaborate effectively
Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings)
A project leader; ability to collaborate with key stakeholders and completes tasks independently at a project level
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
Preferred Skills and Experience:
Oncology trial experience, PK/PD experience
Good working knowledge of reporting processes and software development life-cycle (SDLC)
Utilizes and contributes to the development of standard departmental SAS macros
Ability and interest to work across cultures and geographies
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Requisition ID: R83593
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