3 days ago

Principal Biostatistician (Integrated analysis experience required) EU based

Syneos Health

Netherlands

3 days ago

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Syneos Health is seeking a Principal Biostatistician to lead biostatistics activities across multiple studies or programs, serving as the primary sponsor contact and providing statistical consultancy. The role requires a graduate degree in biostatistics, integrated analysis experience, and strong submission and clinical development expertise. This is a full-time, on-site position based in the Netherlands.

On-siteFull-timePrincipalBiostatisticsIntegrated Analysis

Principal Biostatistician (Integrated analysis experience required) EU based

Apply

On-siteFull-timePrincipalBiostatistics

Salary

Not specified

Work Location

Netherlands, NL

Work Model

On-site

Employment Type

Full-time

Experience Level

Principal

Core Qualifications

Technical (Must-have)

BiostatisticsIntegrated analysisIASAPTLF specificationsStatistical Analysis Plans (SAPs)Randomization scheduleProgrammingSASClinical trialsRegulatory submissionsICH guidelinesData Safety Monitoring Board (DSMB)Data Monitoring Committee (DMC)Benefit/Risk analyses

Soft Skills

MentoringCommunicationLeadershipProblem solvingTime managementCollaborationAdaptability

Preferred Qualifications

Technical (Nice-to-have)

Regulatory submissions experience

Key Responsibilities

•Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
•Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
•Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
•Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
•May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
•Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
•Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
•Implements company objectives, and creates alternative solutions to address business and operational challenges.
•Interfaces with other departmental project team representatives as biostatistics representative.
•Conducts and participates in verification and quality control of project deliverables.
•May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions.
•Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management.
•Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
•Provides statistical programming support as needed.
•May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
•Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
•Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs.
•Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
•Performs other work-related duties as assigned.
•Minimal travel may be required.

BiostatisticianBiotechnology ResearchClinical TrialsIntegrated AnalysisRegulatory SubmissionsSASPrincipalFull-timeOn-siteNetherlands

Core Qualifications

Technical (Must-have)

Soft Skills

MentoringCommunicationLeadershipProblem solvingTime managementCollaborationAdaptability

Key Responsibilities

•Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.

•Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.

•Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.

•Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.

•May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.

•Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

•Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.

•Implements company objectives, and creates alternative solutions to address business and operational challenges.

•Interfaces with other departmental project team representatives as biostatistics representative.

•Conducts and participates in verification and quality control of project deliverables.

•May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions.

•Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management.

•Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.

•Provides statistical programming support as needed.

•May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.

•Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).

•Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs.

•Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

•Performs other work-related duties as assigned.

•Minimal travel may be required.