Biostatistics Manager, Centralized Statistical Monitoring (CSM)
Amgen · Hyderabad · onsite · Posted 52d ago
Undisclosed8–13 yrsfulltimeSourced from
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About this role
Biostatistics Manager, Centralized Statistical Monitoring (CSM)
What you will do:
Amgens Center for Design and Analysis Organization has a new opportunity for a Biostatistics Manager to provide statistical expertise in support of Centralized Statistical Monitoring (CSM) across clinical development programs.
The ideal candidate will build machine learning models and other statistical models, as well as support their implementation and deployment through a good understanding of the Software Development Life Cycle (SDLC). Develop business requirements through collaborations with cross-functional stakeholders and the use of excellent communication skills. Experience with clinical trials and their data collection process, storage, quality, and use would be looked for. The latter will be particularly critical in a regulated environment.
In this role, you will leverage your experience as a biostatistician to contribute to the design, application, and continuous improvement of data-driven monitoring methods that support risk-based quality management (RBQM). You will apply your ML and AI skills to detect atypical data patterns, identify emerging quality risks, and enhance proactive oversight of clinical trials.
Functional requirements, prototype code, good documentation, testing, and relevant visualizations will be expected as deliverables when producing new algorithms as required by the stakeholders.
Key responsibilities include:
- Provide statistical and data science expertise to support CSM activities across multiple studies and therapeutic areas.
- Develop and enhance statistical, machine learning, and AI-guided methodologies, to strengthen CSM signal detection and site-level risk assessment.
- Perform detailed statistical review and quality control of CSM outputs, signals, and study-level metrics to ensure accuracy, consistency, and appropriate interpretation prior to stakeholder communication.
- Collaborate with cross-functional partners (e.g., Clinical, Operations, Data Management, RBQM, Quality, Digital/Technology teams) to translate critical-to-quality (CTQ) factors into analytically robust and scalable monitoring solutions.
- Contribute to validation, documentation, and controlled deployment of analytical methodologies and tools within regulated environments, ensuring reproducibility and adherence to internal standards.
- Develop clear visualizations, dashboards, and analytical applications to enhance transparency and facilitate interpretation of monitoring outputs.
- Stay current with evolving developments in data science, machine learning, and AI relevant to clinical trial monitoring.
- Adhere to all Amgen policies and Standard Operating Procedures (SOPs).
What we expect of you:
The statistical professional we seek is strong in the following qualifications.
Basic Qualifications:
- MSc or PhD in Statistics, Biostatistics, or related field with 8years of Industrial experience.
Preferred Qualifications:
- Proficiency in statistical programming (e.g., R, SAS, or Python) with demonstrated experience applying machine learning and advanced analytical methods in practice.
- Clinical trial experience within a pharmaceutical or medical research environment.
- Prior experience serving as a study statistician for clinical trials, with responsibility for study-level statistical analysis and reporting.
- Experience working effectively in a globally dispersed team environment with cross-cultural partners.
- Demonstrable strategic thinking skills, originality, and creativity.
- Writing skills with samples of technical writing (papers, reports, or project descriptions).
- Self-directed, and well organized.
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Skills
clinical trialsBusiness RequirementsProgrammingclinical developmentMedical ResearchdeploymentData CollectionCommunication SkillsAlgorithmsData ManagementoperationsPharmaceuticalData ScienceArtificial IntelligenceMachine Learning
About Amgen
Amgen
Biotechnology
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