Astrum

Scientist

• Lead the Pharmacometrics function
• Provide PK/PD scientific leadership across consultancy services, R&D, and Phase I/II studies
• Develop and mentor the team
• Define the department’s scientific strategy
• Provide PK/PD expertise to project teams and sponsors
• Oversee PK/PD analyses, modelling, and simulation
• Contribute to protocols, statistical analysis plans, and study reports
• Manage workloads and resource allocation
• Ensure regulatory compliance and inspection readiness
• Implement corrective and preventive actions (CAPAs)
• Support business development
• Promote continuous process improvement

Explore Pharmacometrics Scientist at Astrum. Review requirements and application details.

Pharmacometrics Scientist

Clinical Research

• Lead, develop, and support the RA/PV team
• Manage workloads and serve as the primary regulatory and safety contact for clients
• Oversee clinical trial submissions and communications with Regulatory Authorities and Ethics Committees
• Provide regulatory sign-off on key study documents
• Manage safety reporting, including SUSARs, ICSRs via EudraVigilance, PSURs, and ASRs
• Manage signal detection, safety databases, and Safety Management Plans
• Act as the EU or Local QPPV, or Deputy, where required
• Oversee the PSMF and RMP
• Ensure GVP compliance and inspection readiness
• Support business development and continuous process improvement

Explore Regulatory Affairs – Pharmacovigilance Manager at Astrum. Review requirements and application details.

Regulatory Affairs – Pharmacovigilance Manager

• Provide statistical leadership across Phase II–IV clinical studies
• Develop statistical and analytical strategies for clinical trials
• Define sample sizes, randomization strategies, and estimands
• Author Statistical Analysis Plans (SAPs)
• Review tables, figures, and listings (TFLs)
• Review Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs)
• Review and approve programming specifications, statistical outputs, and analysis datasets prepared by statistical programmers
• Present and defend statistical decisions in client meetings
• Serve as a trusted partner to internal teams and clients
• Support clinical development decisions through technical expertise, client engagement, and strategic thinking

Explore Senior Biostatistician at Astrum. Review requirements and application details.

Senior Biostatistician

• Provide statistical leadership across Phase II–IV clinical studies
• Develop statistical and analytical strategies for clinical trials
• Perform sample size calculations
• Develop randomization strategies
• Define estimands
• Author Statistical Analysis Plans (SAPs)
• Review tables, figures, and listings (TFLs)
• Review Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs)
• Review and approve programming specifications, statistical outputs, and analysis datasets prepared by statistical programmers
• Present and defend statistical decisions in client meetings
• Shape statistical strategy throughout the clinical trial lifecycle, from protocol development and study design through analysis, interpretation, and regulatory documentation
• Serve as a trusted partner to internal teams and clients

• Lead the Pharmacometrics function
• Provide PK/PD scientific leadership across consultancy services, R&D, and Phase I/II studies
• Develop and mentor the team
• Define the department’s scientific strategy
• Provide PK/PD expertise to project teams and sponsors
• Oversee PK/PD analyses, modelling, and simulation
• Contribute to protocols, statistical analysis plans (SAPs), and study reports
• Manage workloads and resource allocation
• Ensure regulatory compliance and inspection readiness
• Implement corrective and preventive actions (CAPAs) in a timely manner
• Support business development
• Promote continuous process improvement

• Plan, execute and monitor clinical trials from site initiation through close-out
• Ensure compliance with regulatory requirements, ICH-GCP and study protocols
• Prioritise patient safety, data integrity and timelines
• Assess potential sites based on capabilities, recruitment potential, staff experience and suitability
• Ensure studies are conducted according to protocols, ICH-GCP, applicable regulations and company policies
• Verify CRFs, source documents and regulatory binders
• Identify, document and report protocol deviations and implement corrective and preventive actions
• Support participant recruitment and retention through screening and eligibility processes
• Monitor patient safety and report Serious Adverse Events (SAEs)
• Lead close-out activities and confirm completeness of study data and documentation
• Conduct on-site and remote monitoring visits, including pre-study, initiation, routine, accompanied and close-out visits
• Apply Risk-Based Monitoring principles
• Resolve data queries with site staff and Data Management
• Review and collect essential documents and support regulatory submissions
• Ensure accurate (e)TMF filing with the Clinical Trial Administrator
• Train site personnel on protocols, compliance requirements and safety procedures
• Act as primary point of contact for study sites
• Collaborate with Project Managers and investigators to keep trials on track

Explore Clinical Research Associate at Astrum. Review requirements and application details.

Clinical Research Associate

Data Scientist

• Lead and develop the Data Management team, overseeing workload, resource allocation and performance
• Oversee key Data Management deliverables, including DMPs, DVPs and UAT documentation, ensuring quality and inspection readiness
• Identify and mitigate risks affecting data quality, timelines and budgets
• Ensure the timely implementation of CAPAs
• Monitor departmental budgets and KPIs
• Drive process improvements and operational efficiency
• Support business development activities through budget specifications, capability presentations and bid defences

Explore Data Manager at Astrum. Review requirements and application details.

Data Manager

• Provide statistical leadership across Phase II–IV clinical studies
• Develop statistical and analytical strategies for clinical trials
• Perform sample size calculations
• Develop randomization strategies
• Define estimands
• Author Statistical Analysis Plans (SAPs)
• Review tables, figures, and listings (TFLs)
• Review Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs)
• Review and approve programming specifications, statistical outputs, and analysis datasets prepared by statistical programmers
• Present and defend statistical decisions in client meetings
• Shape statistical strategy from protocol development and study design through analysis, interpretation, and regulatory documentation
• Partner with internal teams and clients on clinical development decisions

• Plan, execute and monitor clinical trials from site initiation through close-out
• Ensure compliance with regulatory requirements, ICH-GCP and study protocols
• Prioritise patient safety, data integrity and timelines
• Assess potential sites based on capabilities, recruitment potential, staff experience and suitability
• Ensure studies are conducted according to protocols, ICH-GCP, regulations and company policies
• Verify CRFs, source documents and regulatory binders are accurate, complete and current
• Identify, document and report protocol deviations and ensure corrective and preventive actions
• Support participant recruitment and retention through screening and eligibility processes
• Monitor patient safety and ensure timely, accurate reporting of Serious Adverse Events
• Lead close-out activities and confirm completeness of study data and documentation
• Conduct on-site and remote monitoring visits, including pre-study, initiation, routine, accompanied and close-out visits
• Apply Risk-Based Monitoring principles to focus oversight on patient safety and data integrity
• Resolve data queries with site staff and Data Management
• Review and collect essential documents, support regulatory submissions and ensure accurate eTMF filing
• Train site personnel on protocols, compliance requirements and safety procedures
• Act as primary contact for study sites and collaborate with Project Managers and investigators

Open roles

Pharmacometrics Scientist

Regulatory Affairs – Pharmacovigilance Manager

Senior Biostatistician

Senior Biostatistician

Pharmacometrics Scientist

Clinical Research Associate

Data Manager

Senior Biostatistician

Clinical Research Associate