Associate Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM) (Remote)
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within Merck’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 Associate Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.
The incumbent will be responsible for continuous improvement of our electronic submission process 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 statistical programming, statistics, regulatory and other project stakeholders and ensures 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.
PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA).
Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise.
Up-versioning activities to specific versions of SDTM.
Participation in industry teams and conferences on best practices.
Membership on departmental strategic initiative project teams.
Education and Minimum Requirements:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment.
Required Experience and Skills:
Excellent interpersonal skills and ability to negotiate and collaborate effectively.
Excellent written, oral, and presentation skills.
Broad knowledge and significant experience in developing analysis and reporting deliverables for research & development (R&D) projects (data, analyses, tables, graphics, listings).
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
United States and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG.
Demonstrated success in the assurance of deliverable quality and process compliance.
Excels in technical writing, able to convert complex ideas and information into simple readable form.
Strong project management skills.
Familiarity with clinical data management concepts.
Strategic thinking - ability to turn strategy into tactical activities.
Ability to anticipate stakeholder requirements.
Preferred Experience and Skills:
Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC).
Providing technical and/or programming guidance and mentoring to colleagues.
Deals well with change and seamlessly assimilates to new projects and stakeholders.
Ability and interest to work across cultures and geographies.
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.
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” 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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Flexible Work Arrangements:Flex Time, Remote Work, Telecommuting
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