Key skills
PythonRLeadershipProject ManagementPresentation Skills
About this role
Role Overview
- 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
- Keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning
- 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 ensuring project plans are executed efficiently with timely and high quality deliverables
- Serves as the statistical programming point of contact and knowledge holder for assigned projects
- 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
- Develop SAS Macros and Python Functions and Derivations for SDTM Conversions
- Participation in industry teams and conferences on best practices
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 or more 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
- 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 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
- US 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, 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
- Strong Technical Knowledge with experience in Python and SAS
- Familiarity with clinical data management concepts
- Strategic thinking
- ability to turn strategy into tactical activities
- Ability to anticipate stakeholder requirements
Tech Stack
- Python
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