Sr. Scientist Stat Programming, Late-Stage Development (Hybrid)
Merck
10 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Support statistical programming for late-stage drug/vaccine clinical development; may lead one or more projects.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy datasets, tables, listings, figures) from clinical trials through 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 deliver timely, high-quality outputs; serve as statistical programming point of contact and knowledge holder across the product lifecycle.
Primary Activities:
- Develop, validate, and program analyses/reports using global/therapeutic area standards, SOPs, and good programming practices.
- Maintain and manage project plan (including resource forecasting).
- Coordinate a global programming team, including outsourced provider staff.
- Participate in departmental strategic initiative teams.
Education:
- BA/BS (CS/Statistics/Applied Math/Life Sciences/Engineering or related) + 5+ years SAS programming in a clinical trial environment.
- MS (same fields) + 3+ years SAS programming in a clinical trial environment.
Required Skills/Experience:
- Interpersonal, negotiation, and collaboration; strong written/oral/presentation skills.
- Experience producing analysis and reporting deliverables (data/analyses/tables/graphics/listings); project leadership.
- SAS clinical trial programming expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems/database expertise.
- Ability to interpret analysis plans; knowledge of clinical data management concepts.
- Experience with CDISC and ADaM; ensure process compliance and deliverable quality.
- Strategic thinking; anticipate stakeholder requirements.
Preferred Skills:
- R for modeling/analysis/visualization; SDLC/SOP knowledge; regulatory submission experience (electronic submission deliverables).
- Mentoring/ensuring cross-protocol programming consistency; work across geographies; manage plans (Microsoft Project or similar); professional society involvement; process improvement.
Application:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub). Application deadline is on the posting.
Benefits (if applicable as stated):
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
- Support statistical programming for late-stage drug/vaccine clinical development; may lead one or more projects.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy datasets, tables, listings, figures) from clinical trials through 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 deliver timely, high-quality outputs; serve as statistical programming point of contact and knowledge holder across the product lifecycle.
Primary Activities:
- Develop, validate, and program analyses/reports using global/therapeutic area standards, SOPs, and good programming practices.
- Maintain and manage project plan (including resource forecasting).
- Coordinate a global programming team, including outsourced provider staff.
- Participate in departmental strategic initiative teams.
Education:
- BA/BS (CS/Statistics/Applied Math/Life Sciences/Engineering or related) + 5+ years SAS programming in a clinical trial environment.
- MS (same fields) + 3+ years SAS programming in a clinical trial environment.
Required Skills/Experience:
- Interpersonal, negotiation, and collaboration; strong written/oral/presentation skills.
- Experience producing analysis and reporting deliverables (data/analyses/tables/graphics/listings); project leadership.
- SAS clinical trial programming expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems/database expertise.
- Ability to interpret analysis plans; knowledge of clinical data management concepts.
- Experience with CDISC and ADaM; ensure process compliance and deliverable quality.
- Strategic thinking; anticipate stakeholder requirements.
Preferred Skills:
- R for modeling/analysis/visualization; SDLC/SOP knowledge; regulatory submission experience (electronic submission deliverables).
- Mentoring/ensuring cross-protocol programming consistency; work across geographies; manage plans (Microsoft Project or similar); professional society involvement; process improvement.
Application:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub). Application deadline is on the posting.
Benefits (if applicable as stated):
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.