Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
The Associate Principal Scientist, Statistical Programming-Oncology 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 datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Key areas of focus include: (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and therapeutic area (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, and (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.
Responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
Is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
Serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects.
Education Minimum Requirements:
Bachelor's or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering.
BS plus 9-12 years or MS plus 7+ years SAS programming experience in a clinical trial environment.
Required Experience and Skills:
Directing 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, /MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.
United States and/or worldwide drug or vaccine regulatory application submission knowledge at the leadership level including the development of electronic submission deliverables.
Strong project management skills.
A program leader: establishes 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.
Comprehension 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.
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.
CDISC and ADaM standards skills.
Demonstrated success in the assurance of deliverable quality and process compliance.
Ability to anticipate stakeholder and regulatory requirements.
Preferred Experience and Skills:
Strong working knowledge of reporting processes, standard operating procedures (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.
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
Developing and managing a project plan using Microsoft Project or similar package.
Active in professional societies.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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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Flexible Work Arrangements:
Flex Time, Work Week
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