Sr. Scientist, Stat. Programming - SDTM; Hybrid

Responsibilities

The Senior Statistical Programmer, Submission Data Standards Quality Management (SDSQM) oversees and manages the quality of submission data standard deliverables for worldwide regulatory application submissions of drug and vaccine clinical development projects. Responsibilities include submission data standards planning, coaching and consulting with project teams, outreach to external vendors and partners, staying current with industry submission data standards such as SDTM, ADaM, and coordinating with statistical programming, statistics, regulatory and other stakeholders.

• Prepare for Pre‑NDA and Pre‑BLA meetings, develop study data standards plans, and prepare questions for FDA e‑data mailboxes (CBER/CDER) and attend meetings with regulatory agencies (FDA, EMA, PMDA).
• Guide project teams in preparing submission deliverables, including use of Pinnacle 21 Enterprise.
• Manage up‑versioning activities to specific versions of SDTM.
• Participate in industry teams and conferences on best practices.
• Serve on departmental strategic initiative project teams.

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years of SAS programming experience in a clinical trial environment.
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years of SAS programming experience in a clinical trial environment.

• Effective interpersonal skills and ability to negotiate and collaborate effectively.
• Effective written, oral, and presentation skills.
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Project leadership: completes tasks independently at a project level and collaborates with key stakeholders.

• Experience with US and/or worldwide drug or vaccine regulatory application submissions, including electronic submission deliverables.
• Experience with CDISC standards (SDTM, ADaM), Define.
  
  XML, cSDRC, ADRG.
• Demonstrated success in assuring deliverable quality and process compliance.
• Strong technical writing skills, ability to translate complex ideas into simple readable form.
• Solid project management skills.
• Familiarity with clinical data management concepts.
• Strategic thinking—ability to translate strategy into tactical activities.
• Ability to anticipate stakeholder requirements.

• 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 ensuring 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 similar package.
• Active in professional societies.
• Experience in process improvement.