Job Description
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.
The Senior Statistical Programmer, Submission Data Standards Quality Management (SDSQM), 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
Education and Minimum Requirement
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years of SAS programming experience in a clinical trial environment
- OR
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 years of SAS programming experience in a clinical trial environment
Department Required Skills and Experience
- 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
- Position Specific Required Skills and Experience:
- US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
- Experience with submission standards CDISC (SDTM, ADaM), Define.XML, SDRG, 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
- Solid project management skills
- Familiarity with clinical data management concepts
- Strategic thinking - ability to turn strategy into tactical activities
- Ability to anticipate stakeholder requirements
Preferred Skills and Experience
- Working knowledge or R and Python programming languages for data analysis, automation, and clinical data standards activities
- 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
- Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
- Experience developing and managing a project plan using Microsoft Project or similar package
- Active in professional societies
- Experience in process improvement
