Sr. Scientist Stat Programming, Late-Stage Development (Hybrid)
Merck
9 hours ago
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Responsibilities:
- Support statistical programming activities for late-stage drug/vaccine clinical development projects; may lead one or more projects.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy analysis datasets, tables, listings, figures) spanning trials through worldwide regulatory submissions and post-marketing support.
- Design and maintain statistical datasets supporting multiple stakeholder groups (clinical development, outcomes research, safety evaluation).
- Collaborate with statistics and project stakeholders to ensure timely, high-quality deliverables.
- Serve as statistical programming point of contact and knowledge holder through the product lifecycle.
Primary Activities:
- Develop, validate, and implement analysis/report programming using global/TA standards, departmental SOPs, and good programming practices.
- Maintain and manage project plan, including resource forecasting.
- Coordinate activities of a global programming team (including outsource provider staff).
- Participate in departmental strategic initiative teams.
Education Minimum Requirement:
- BA/BS plus 5+ years SAS programming experience in a clinical trial environment.
- MS plus 3+ years SAS programming experience in a clinical trial environment.
Required Skills/Experience:
- Interpersonal, negotiation, collaboration; strong written/oral/presentation skills.
- Experience creating R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings).
- Ability to independently complete project-level tasks and collaborate with stakeholders.
- SAS clinical trial programming expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) and systems/database expertise.
- Ability to design complex programming algorithms; understand analysis plans and statistical terminology.
- Familiarity with clinical data management; experience with CDISC and ADaM standards.
- Ensure process compliance and deliverable quality; strategic thinking and stakeholder requirement anticipation.
Preferred Skills/Experience:
- R programming for statistical modeling/analysis/visualization.
- Regulatory application submission experience (including electronic submission deliverables).
- Program consistency across protocols/projects; mentorship; cross-cultural/geographic teamwork.
- Experience using global outsource partner staff; Microsoft Project (or similar) for planning.
- Process improvement; active professional society involvement.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).
- Support statistical programming activities for late-stage drug/vaccine clinical development projects; may lead one or more projects.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy analysis datasets, tables, listings, figures) spanning trials through worldwide regulatory submissions and post-marketing support.
- Design and maintain statistical datasets supporting multiple stakeholder groups (clinical development, outcomes research, safety evaluation).
- Collaborate with statistics and project stakeholders to ensure timely, high-quality deliverables.
- Serve as statistical programming point of contact and knowledge holder through the product lifecycle.
Primary Activities:
- Develop, validate, and implement analysis/report programming using global/TA standards, departmental SOPs, and good programming practices.
- Maintain and manage project plan, including resource forecasting.
- Coordinate activities of a global programming team (including outsource provider staff).
- Participate in departmental strategic initiative teams.
Education Minimum Requirement:
- BA/BS plus 5+ years SAS programming experience in a clinical trial environment.
- MS plus 3+ years SAS programming experience in a clinical trial environment.
Required Skills/Experience:
- Interpersonal, negotiation, collaboration; strong written/oral/presentation skills.
- Experience creating R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings).
- Ability to independently complete project-level tasks and collaborate with stakeholders.
- SAS clinical trial programming expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) and systems/database expertise.
- Ability to design complex programming algorithms; understand analysis plans and statistical terminology.
- Familiarity with clinical data management; experience with CDISC and ADaM standards.
- Ensure process compliance and deliverable quality; strategic thinking and stakeholder requirement anticipation.
Preferred Skills/Experience:
- R programming for statistical modeling/analysis/visualization.
- Regulatory application submission experience (including electronic submission deliverables).
- Program consistency across protocols/projects; mentorship; cross-cultural/geographic teamwork.
- Experience using global outsource partner staff; Microsoft Project (or similar) for planning.
- Process improvement; active professional society involvement.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).