Senior Scientist, Statistical Programming - SDTM (Hybrid)

MSD • North Wales, PA

1d • $117,000 - $184,200 • Hybrid

About The Position

Within BARDS (Biostatistics and Research Decision Sciences), part of the Research and Development division, the Senior Statistical Programmer in Submission Data Standards Quality Management (SDSQM) provides oversight and quality management for submission data standard deliverables supporting worldwide regulatory applications for drug and vaccine clinical development projects. The role focuses on submission data standards planning, coaching and consulting with project teams, engaging external vendors and partners, and staying current with industry standards such as SDTM, ADaM, and clinical site data for CDER inspection planning.

The position supports continuous improvement of the electronic submission process and develops tools and templates to promote traceability, quality assurance, data conformance, and data fitness. It collaborates with statistical programming, statistics, regulatory, and other project stakeholders. Work includes preparing for PreNDA and PreBLA meetings, developing study data standards plans, preparing questions for FDA e-data mailboxes, attending meetings with regulatory agencies, guiding teams on submission deliverables and Pinnacle 21 Enterprise, supporting SDTM up-versioning, and participating in industry and departmental initiatives.

Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field, plus 5 years of SAS programming experience in a clinical trial environment; or an MS in one of these fields, plus 3 years of such experience.
• Effective interpersonal skills and ability to negotiate and collaborate effectively.
• Effective written, oral, and presentation skills.
• Knowledge and experience developing analysis and reporting deliverables for R&D projects, including data, analyses, tables, graphics, and listings.
• Ability to lead projects and complete tasks independently at the project level while collaborating with key stakeholders.
• US and/or worldwide drug or vaccine regulatory application submission experience, including development of electronic submission deliverables.
• Experience with CDISC submission standards, including SDTM and ADaM, as well as Define.XML, cSDRG, and ADRG.
• Demonstrated success assuring deliverable quality and process compliance.
• Strong technical writing skills, including the ability to communicate complex ideas and information clearly.
• Solid project management skills.
• Familiarity with clinical data management concepts.
• Strategic thinking and ability to translate strategy into tactical activities.
• Ability to anticipate stakeholder requirements.
• Required skills include CDISC standards, data management, data modeling, numerical analysis, stakeholder relationship management, SDTM, and the Waterfall Model.

Nice To Haves

• Hands-on experience with R and Python for data analysis and statistical modeling.
• Strong working knowledge of reporting processes (SOPs) and the software development life cycle (SDLC).
• Experience assuring consistency across protocols and projects.
• Ability and interest in working across cultures and geographies.
• Experience developing and managing project plans using Microsoft Project or a similar package.
• Active participation in professional societies.
• Experience in process improvement.

Responsibilities

• Provide oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions.
• Plan submission data standards and coach and consult with project teams.
• Conduct outreach to external vendors and partners and keep current with industry submission data standards, including SDTM, ADaM, and clinical site data for CDER inspection planning.
• Continuously improve the electronic submission process and provide tools and templates supporting traceability, quality assurance, data conformance, and data fitness.
• Collaborate with statistical programming, statistics, regulatory, and other project stakeholders.
• Prepare for PreNDA and PreBLA meetings and develop study data standards plans.
• Prepare questions for FDA CBER/CDER e-data mailboxes and attend meetings with regulatory agencies, including FDA, EMA, and PMDA.
• Guide project teams preparing submission deliverables, including use of Pinnacle 21 Enterprise.
• Perform up-versioning activities to specific SDTM versions.
• Participate in industry teams and conferences on best practices.
• Participate in departmental strategic initiative project teams.
• Complete project-level tasks independently and collaborate with key stakeholders.
• Provide statistical programming deliverables through global outsource partner programming staff, as applicable.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior