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.
The Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and validation of Case Report Tabulation (SDTM) study data deliverables (SDTM dataset, Define Extensible Markup Language (XML), Study Data Reviewer Guide (SDRG), Annotated Case Report Form (aCRF)), collaborating and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.
The incumbent will be responsible for continuous improvement of our electronic submission process for study data standard deliverables and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.
Supporting project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission
Supporting project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise
Up-versioning activities to specific versions of SDTM
Develop Statistical Analysis System (SAS) programs, standards macros to enhance the process
Collaborate effectively with project team members
Participation in industry teams and conferences on best practices
Membership on departmental strategic initiative project teams
Bachelor of Arts or Science (BA/BS) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering with a minimum of five (5) years SAS programming experience in a clinical trial environment.
Required Experience and Skills:
Experience with study data standards CDISC (SDTM)
Experience in SAS and clinical programming
Knowledge and experience in developing analysis and reporting deliverables for Research & Development projects(data, analysis, tables, graphics, listings)
Excellent communication and negotiation skills / excellent teamwork and collaboration
Excellent written and verbal, and presentation skills; effective technical writing, able to convert complex ideas and information into simple readable form
A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
Solid project management skills
Demonstrated success in the assurance of deliverable quality and process compliance
Familiarity with statistical and clinical data management concepts
Preferred Experience and Skills:
Strong working knowledge of reporting processes Standard Operating Procedure (SOP) and software development life-cycle (SDLC)
Experience ensuring consistency across protocols and projects
Strategic thinking ability to turn strategy into tactical activities
Ability and interest to work across cultures and geographies
Ability to complete statistical deliverables using global outsource partner programming staff
Experience developing and managing a project plan using Microsoft Project or similar package
Active in industry forums and professional societies
Experience in process improvement
Knowledge of Metadata Repositories (MDR)
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., 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.
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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 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:
$96,700.00 - $164,500.00
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