Senior Scientist, Statistical Programming - SDTM (Hybrid)

Merck•Rahway, NJ

12h•$117,000 - $184,200•Hybrid

About The Position

Within BARDS (Biostatistics and Research Decision Sciences), part of Research and Development, the Senior Statistical Programmer in Submission Data Standards Quality Management (SDSQM) oversees and quality-manages submission data standard deliverables for worldwide regulatory applications for drug and vaccine clinical development projects. The role primarily supports submission data standards planning, coaches and consults with project teams, coordinates with external vendors and partners, and maintains current knowledge of industry submission standards, including SDTM, ADaM, and clinical site data for CDER inspection planning. The position supports continuous improvement of the electronic submission process and provides tools and templates focused on 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, and participating in SDTM up-versioning, industry activities, and departmental strategic 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; alternatively, 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, complete tasks independently at a project level, and collaborate with key stakeholders.
Experience with US and/or worldwide drug or vaccine regulatory application submissions, including development of electronic submission deliverables.
Experience with CDISC submission standards, including SDTM, ADaM, Define.XML, cSDRG, and ADRG.
Demonstrated success assuring deliverable quality and process compliance.
Strong technical writing ability, including translating complex ideas and information into clear, readable form.
Solid project management skills.
Familiarity with clinical data management concepts.
Strategic thinking and ability to turn strategy into tactical activities.
Ability to anticipate stakeholder requirements.
Required skills listed: CDISC standards, data management, data modeling, numerical analysis, stakeholder relationship management, SDTM, and 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 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 global outsource partner programming staff.
Experience developing and managing a project plan using Microsoft Project or a similar package.
Active participation in professional societies.
Experience in process improvement.

Responsibilities

Oversee and quality-manage submission data standard deliverables for worldwide regulatory application submissions for drug and vaccine clinical development projects.
Lead submission data standards planning and coach and consult with project teams.
Conduct outreach to external vendors and partners and stay 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, develop study data standards plans, prepare questions for FDA 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.