Senior Scientist, Statistical Programming - Late Stage Oncology
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
This position supports statistical programming activities for late stage drug/vaccine 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), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
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.
For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
Effective analysis and report programming development and validation utilizing global and therapeutic area (TA) standards and following departmental standard operating procedures (SOPs) and good programming practices.
Maintain and manage a project plan including resource forecasting.
Coordinate the activities of a global programming team that includes outsource provider staff.
Membership on departmental strategic initiative teams.
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field and a minimum of 5 years' SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field and a minimum of 3 years' SAS programming experience in a clinical trial environment.
Required Experience and Skills:
Effective interpersonal skills and ability to negotiate and collaborate effectively.
Effective written, oral, and presentation skills.
Effective knowledge and experience in developing analysis and reporting deliverables for Research and Development projects (data, analyses, tables, graphics, listings).
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders. Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
Designs and develops complex programming algorithms.
Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
Familiarity with clinical data management concepts.
Experience in Clinical Data Interchange Standards Consortium (CDISC) and Analysis Dataset Model (ADaM) standards.
Experience ensuring process compliance and deliverable quality.
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.
Ability to anticipate stakeholder requirements.
Preferred Experience and Skills:
Demonstrated success in the assurance of deliverable quality and process compliance.
Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
United States and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor.
Ability and interest to work across cultures and geographies.
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
Experience developing and managing a project plan using Microsoft Project or similar package.
Active in professional societies.
Experience in process improvement.
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., Rahway, 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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$93,900.00 - $159,700.00
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Travel Requirements:No Travel Required
Flexible Work Arrangements:Flex Time
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Number of Openings:5