Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (Hybrid)

MSD•North Wales, PA

7d•Hybrid

About The Position

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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. Responsibilities: The Senior 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. Primary Activities: 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

Requirements

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment
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 R&D projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at a project level; Ability to collaborate with key stakeholders
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
In-depth knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml).
Proficiency in diverse data collection methods, including eCRF, IRT, and central lab data
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
Solid project management skills
Strategic thinking - ability to turn strategy into tactical activities
Ability to anticipate stakeholder requirements
Accountability
Clinical Trials
Data Management
Data Modeling
Electronic Submissions
Information Systems Management
Innovation
Machine Learning (ML)
Microsoft Project
Numerical Analysis
Process Improvement Projects
Process Improvements
Project Management
Regulatory Compliance
REMOTE_SKILL-1-52891
Stakeholder Relationship Management
Statistical Programming
Technical Writing
Waterfall Model

Nice To Haves

Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Experience assuring consistency across protocols and projects
Ability and interest to work across cultures and geographies
Knowledge of clinical data metadata & information management platforms and systems.
Experience using SAS, R, and Python to generate data-driven insights
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Experience developing and managing a project plans in Microsoft Project or similar tools
Active participation in professional societies
Experience leading or contributing to process improvement initiatives

Responsibilities

The Senior 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.
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

Benefits

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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