Own capacity planning, prioritization and delivery governance for the team’s study, program and capability work; balance urgent study needs with reusable, scalable solutions.
Provide technical direction and review for clinical reports, dashboards, visualization standards, data transformations and advanced data-review solutions, remaining sufficiently hands-on to resolve complex issues and make sound technical decisions.
Establish consistent intake, estimation, development, peer-review, testing, release and support practices across the team.
Clinical analytical reporting and data products
Ensure timely, high-quality delivery of patient profiles, listings, cross-domain reports, medical and safety review dashboards, operational metrics, data-quality indicators and other study- and program-level solutions.
Oversee development of curated, analysis-ready clinical datasets that integrate approved EDC and external data and support traceable, repeatable reporting.
Drive adoption of reusable components, standard templates, common data definitions and metadata-driven approaches that reduce duplication and improve consistency.
Sponsor practical use of anomaly detection, advanced analytics and automation to surface data issues, trends and potential risks, with documented validation and appropriate human review.
Cross-functional partnership and operational excellence
Partner with leaders and SMEs in Data Management, Medical Data Review, Safety, Clinical Operations, Biostatistics, Therapeutic Areas, Clinical Systems and Digital Technology to define priorities and fit-for-purpose solutions.
Represent Analytical Reporting in study and program governance; communicate delivery status, risks, trade-offs and decision recommendations clearly to stakeholders.
Manage vendor or contingent-resource delivery within assigned scope, including quality oversight, performance feedback and acceptance of deliverables.
Establish meaningful service, quality and adoption metrics; use findings to drive root-cause analysis, continuous improvement and transparent performance management.
Quality, compliance and capability building
Ensure reporting solutions comply with ICH-GCP, applicable regulations, Amgen policies, data-integrity expectations, privacy and security requirements, and controlled-system practices.
Maintain inspection-ready evidence for development, validation, release and lifecycle management; support audits, inspections and corrective actions.
Contribute to the analytical reporting roadmap, technology evaluation, SOPs, standards and communities of practice; identify emerging needs for the Associate Director.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative, technically credible and patient-focused professional we seek has the following qualifications.
Basic qualifications
Doctorate degree and 5+ years of relevant experience; OR Master’s degree and 8+ years of relevant experience; OR Bachelor’s degree and 10+ years of relevant experience.
2+ years of people-management experience, or demonstrated leadership of a significant technical team or capability, in clinical development, data management, programming, analytics, data science or a related environment.
Demonstrated experience delivering clinical data reports, dashboards, visualizations, analytical datasets or data-review solutions in pharmaceutical, biotechnology, CRO or closely related regulated settings.
Preferred qualifications
Experience leading teams that use SQL, Python, SAS, R, Databricks, Power BI, Spotfire, Tableau or comparable platforms.
Strong understanding of clinical development and data-review workflows, EDC and external clinical data, CDISC standards, data governance and regulated-system validation.
Experience building operating practices, capacity plans, quality metrics and vendor-management models in a global matrix environment.
Experience evaluating AI, machine learning or intelligent automation in a regulated setting, including validation, traceability and human-oversight considerations.
Strong stakeholder management, change leadership, communication and talent-development skills.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
