Assoc Principal Scientist Statistical Programming, Late-Stage (Hybrid)
Merck
11 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Key Areas Of Focus
- Ensure deliverable quality and process compliance.
- Develop deliverables using global and TA standards; optimize analysis/reporting and promote a strategic knowledge-base data model.
- Maintain and manage project plan, including resource forecasting.
- Coordinate a global programming team, including outsource providers.
- Participate in departmental strategic initiative teams (e.g., new statistical computing platform evaluation/development).
Responsibilities
- Support statistical programming for multiple/large/complex late-stage drug/vaccine clinical development projects.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy datasets, tables/listings/figures).
- Design and maintain statistical databases supporting multiple stakeholder groups.
- Collaborate with statistics and stakeholders to deliver timely, high-quality outputs.
- Serve as statistical programming point of contact and knowledge holder across the product lifecycle.
Education And Minimum Requirement
- BA/BS (CS, Statistics, Applied Math, Life Sciences, Engineering or related) + 9+ years SAS programming in a clinical trial environment.
OR MS (same fields) + 7+ years.
Required Skills/Experience
- Lead large/complex statistical programming projects; coordinate programming teams.
- SAS expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems/database expertise; understand statistical analysis methods and clinical data management concepts.
- Clinical regulatory submission experience (US/worldwide) at leadership level, including electronic submission deliverables.
- Strong project management; programming methodology/program consistency; mentor others; stakeholder engagement.
- Comprehend statistical analysis plans; design/develop complex programming algorithms.
- Excellent communication/negotiation and teamwork.
- Strategic thinking for database design with analysis/reporting optimization.
- CDISC and ADaM standards.
- Anticipate stakeholder and regulatory requirements.
Preferred Skills
- Reporting processes (SOPs) and SDLC knowledge.
- Cross-cultural/geographic experience.
- Technical/programming guidance and mentoring.
- Experience leveraging global outsource partner staff.
- Microsoft Project (or similar) for project planning.
- Process improvement; active in professional societies.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline is stated on the posting.
- Ensure deliverable quality and process compliance.
- Develop deliverables using global and TA standards; optimize analysis/reporting and promote a strategic knowledge-base data model.
- Maintain and manage project plan, including resource forecasting.
- Coordinate a global programming team, including outsource providers.
- Participate in departmental strategic initiative teams (e.g., new statistical computing platform evaluation/development).
Responsibilities
- Support statistical programming for multiple/large/complex late-stage drug/vaccine clinical development projects.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy datasets, tables/listings/figures).
- Design and maintain statistical databases supporting multiple stakeholder groups.
- Collaborate with statistics and stakeholders to deliver timely, high-quality outputs.
- Serve as statistical programming point of contact and knowledge holder across the product lifecycle.
Education And Minimum Requirement
- BA/BS (CS, Statistics, Applied Math, Life Sciences, Engineering or related) + 9+ years SAS programming in a clinical trial environment.
OR MS (same fields) + 7+ years.
Required Skills/Experience
- Lead large/complex statistical programming projects; coordinate programming teams.
- SAS expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems/database expertise; understand statistical analysis methods and clinical data management concepts.
- Clinical regulatory submission experience (US/worldwide) at leadership level, including electronic submission deliverables.
- Strong project management; programming methodology/program consistency; mentor others; stakeholder engagement.
- Comprehend statistical analysis plans; design/develop complex programming algorithms.
- Excellent communication/negotiation and teamwork.
- Strategic thinking for database design with analysis/reporting optimization.
- CDISC and ADaM standards.
- Anticipate stakeholder and regulatory requirements.
Preferred Skills
- Reporting processes (SOPs) and SDLC knowledge.
- Cross-cultural/geographic experience.
- Technical/programming guidance and mentoring.
- Experience leveraging global outsource partner staff.
- Microsoft Project (or similar) for project planning.
- Process improvement; active in professional societies.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline is stated on the posting.