Biostatistical Programming Manager
Amgen
4 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Biostatistical Programming Manager
What You Will Do
- Provide strategic oversight and hands-on statistical programming support to enable high-quality and timely clinical trial deliverables.
- Support urgent and high-priority programming needs across development programs within the Quality and Quick Response (QQR) Programming team.
- Serve as a technical programming expert, rapidly responding to internal/external requests, supporting special projects, providing global quality oversight, and contributing directly to deliverables.
- Primarily support Obesity Therapeutic Area programs, collaborating with cross-functional teams.
Responsibilities
- Provide rapid response statistical programming for urgent requests.
- Serve as lead programmer for studies/projects (e.g., Data Access Plan, unblinding, special projects).
- Deliver hands-on programming support for SDTM, ADaM, Tables/Listing/Figures (TFLs), and other submission deliverables.
- Oversee execution/quality of work managed by FSP partners per GSP Quality Oversight Plan (QOP).
- Ensure FSP and in-house deliverables meet quality, compliance, timeline, and productivity expectations.
- Mitigate at-risk projects via technical expertise and operational guidance.
- Contribute to training (materials and delivery) and provide technical consultancy on Amgen processes/tools.
- Lead/contribute to continuous improvement, inspection readiness, process improvement, innovation, and training.
- Develop performance metrics and review specs/issue logs/deliverable status.
Basic Qualifications
- Doctorate OR Master’s + 2 years; Bachelor’s + 4 years; Associate’s + 8 years; HS/GED + 10 years (statistical programming).
Preferred Qualifications/Skills
- 6+ years biopharmaceutical statistical programming; regulatory submission experience.
- Strong SAS (Base, Macro, SQL, SAS/Graph, Stat), experience with R (preferred), Python (preferred).
- Hands-on SDTM/ADaM/TFL development and validation; clinical trial process knowledge.
- Data standards/compliance (incl. Pinnacle 21); quality oversight of outsourced/internal deliverables.
- Troubleshooting complex issues; global team (Phase 1-4) experience; Obesity TA experience (preferred).
- Excellent English communication; collaboration/negotiation/organizational skills.
Application
- Apply at careers.amgen.com.
What You Will Do
- Provide strategic oversight and hands-on statistical programming support to enable high-quality and timely clinical trial deliverables.
- Support urgent and high-priority programming needs across development programs within the Quality and Quick Response (QQR) Programming team.
- Serve as a technical programming expert, rapidly responding to internal/external requests, supporting special projects, providing global quality oversight, and contributing directly to deliverables.
- Primarily support Obesity Therapeutic Area programs, collaborating with cross-functional teams.
Responsibilities
- Provide rapid response statistical programming for urgent requests.
- Serve as lead programmer for studies/projects (e.g., Data Access Plan, unblinding, special projects).
- Deliver hands-on programming support for SDTM, ADaM, Tables/Listing/Figures (TFLs), and other submission deliverables.
- Oversee execution/quality of work managed by FSP partners per GSP Quality Oversight Plan (QOP).
- Ensure FSP and in-house deliverables meet quality, compliance, timeline, and productivity expectations.
- Mitigate at-risk projects via technical expertise and operational guidance.
- Contribute to training (materials and delivery) and provide technical consultancy on Amgen processes/tools.
- Lead/contribute to continuous improvement, inspection readiness, process improvement, innovation, and training.
- Develop performance metrics and review specs/issue logs/deliverable status.
Basic Qualifications
- Doctorate OR Master’s + 2 years; Bachelor’s + 4 years; Associate’s + 8 years; HS/GED + 10 years (statistical programming).
Preferred Qualifications/Skills
- 6+ years biopharmaceutical statistical programming; regulatory submission experience.
- Strong SAS (Base, Macro, SQL, SAS/Graph, Stat), experience with R (preferred), Python (preferred).
- Hands-on SDTM/ADaM/TFL development and validation; clinical trial process knowledge.
- Data standards/compliance (incl. Pinnacle 21); quality oversight of outsourced/internal deliverables.
- Troubleshooting complex issues; global team (Phase 1-4) experience; Obesity TA experience (preferred).
- Excellent English communication; collaboration/negotiation/organizational skills.
Application
- Apply at careers.amgen.com.