Define technical approaches, solution architectures, data flows, reusable components, development standards and testing strategies for assigned initiatives.
Lead curation, integration and transformation of EDC and approved external clinical data into trusted, analysis-ready datasets with clear lineage, quality controls and fit-for-purpose semantic definitions.
Develop and evaluate anomaly-detection, pattern-recognition, automation and advanced analytical approaches; ensure outputs are interpretable, validated and appropriately reviewed by subject-matter experts.
Provide hands-on expertise with approved languages, platforms and visualization tools, such as SAS, SQL, Python, R, Databricks, Power BI, Spotfire and Tableau, selecting technology based on business need and governed architecture.
Delivery leadership and stakeholder partnership
Translate complex review needs from Data Management, Medical Data Review, Safety, Clinical Operations, Biostatistics, Clinical Systems and Digital Technology into clear requirements, solution designs and prioritized delivery plans.
Act as technical lead for defined studies, programs or capability initiatives; manage dependencies, risks, estimates and delivery milestones and communicate status to stakeholders.
Mentor associate and senior programmers through design reviews, code reviews, troubleshooting and technical coaching; raise team capability without direct people-management accountability.
Lead vendor or external-resource technical activities when assigned, including work review, UAT coordination and acceptance of deliverables.
Quality, governance and innovation
Establish and apply risk-based quality controls for data preparation, programming, visual design, testing, release and maintenance; ensure traceability and inspection readiness.
Contribute to standards, SOPs, work instructions, reusable assets and governance forums for analytical reporting and clinical data review.
Partner with architecture and platform teams to improve scalability, performance, privacy, security, access controls and controlled deployment of reporting solutions.
Identify and pilot high-value improvements in automation, AI-enabled analytics and visualization; recommend scale-up only when value, validation and governance criteria are met.
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
Bachelor’s degree in life sciences, computer science, data science, statistics, bioinformatics, health informatics, engineering or a related discipline and 10+ years of relevant experience; OR Master’s degree and 8+ years of relevant experience; OR Doctorate degree and 5+ years of relevant experience.
Demonstrated experience designing and delivering clinical reports, dashboards, visualizations, analytical datasets or data-review solutions in pharmaceutical, biotechnology, CRO or closely related regulated settings.
Preferred qualifications
Advanced proficiency in SQL and at least one programming language such as Python, SAS or R, plus practical experience with one or more enterprise visualization platforms.
Experience with clinical data models, EDC and external clinical data, CDISC standards, data lineage, metadata-driven development and regulated-system validation.
Experience applying statistical, anomaly-detection, machine-learning or automation methods to clinical data with appropriate validation and human oversight.
Demonstrated technical leadership across cross-functional initiatives, including design authority, mentoring and management of complex delivery risks.
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.
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