Hybrid Senior Scientist, Statistical Programmer, Submission Data Standards Quality Management

at MSD

• Job title: Senior Scientist, Statistical Programmer, Submission Data Standards Quality Management
• Job type: Full Time
• Experience level: Senior
• Salary: $117,000 - $184,200 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, North Wales, United States

About the role

• Senior Statistical Programmer providing oversight and quality management of submission data standards for regulatory applications. Key collaborator with statistical programming and regulatory project stakeholders.

Responsibilities

• 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.
• 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.
• Key collaborator with statistical programming, statistics, regulatory and other project stakeholders
• 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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days