Senior Scientist, Statistical Programming, SDTM; Hybrid

Overview

Senior Statistical Programmer, Submission Data Standards Quality Management (SDSQM), provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions in 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 such as SDTM, ADaM, and clinical site data for CDER inspection planning.

Primary activities include:

• PreNDA and PreBLA meeting preparation
• Study data standards plan development
• 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

• 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 the same fields plus a minimum of 5 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).
• A project leader who completes tasks independently at a project level and collaborates with key stakeholders.
• US and/or worldwide drug or vaccine regulatory application submission experience, including development of electronic submission deliverables.
• Experience with CDISC submission standards (SDTM, ADaM), Define.
  
  XML, SDRG, ADRG.
• Demonstrated success in assurance of deliverable quality and process compliance.
• Strong technical writing skills, able to convert complex ideas into clear, readable form.
• Project management skills.
• Familiarity with clinical data management concepts.
• Strategic thinking – ability to turn strategy into tactical activities.
• Ability to anticipate stakeholder requirements.

• Working knowledge of R and Python programming for data analysis, automation, and clinical data standards activities.
• Knowledge of reporting processes (SOPs) and software development life cycle (SDLC).
• Experience ensuring consistency across protocols and projects.
• Interest in working 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 participation in professional societies.
• Experience in process improvement.

• Salary range: $ - $.
• Eligible for annual bonus and long‑term incentive, if applicable.
• Comprehensive benefits package including medical, dental, vision, and other insurance benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

• Relocation:
  Domestic.
• Visa Sponsorship:
  Yes.
• Travel Requirements: 10%.
• Flexible Work Arrangements:
  Hybrid.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.