1 day ago

Principal Biostatistician Medical Affairs

Syneos Health

Amsterdam

1 day ago

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Principal Biostatistician needed for Medical Affairs at Syneos Health, a leading life sciences services organization. The role involves providing statistical support for exploratory analysis, observational studies, RWE, and publications. Requires previous clinical trial experience and location in specified European countries, UK, or South Africa.

RemoteFull-timePrincipalClinical TrialsStatistical Analysis Plans

Principal Biostatistician Medical Affairs

Apply

RemoteFull-timePrincipalClinical Trials

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Employment Type

Full-time

Experience Level

Principal

Core Qualifications

Technical (Must-have)

Clinical TrialsStatistical Analysis PlansSASRegulatory GuidelinesICHData Safety Monitoring BoardBiostatisticsStatistical ProgrammingRWEObservational Studies

Soft Skills

CollaborationCommunicationProblem SolvingTime ManagementMentoringLeadership

Key Responsibilities

•Provide statistical support to Medical Affairs group for exploratory analysis, observational studies, RWE, and publication support.
•Prepare Statistical Analysis Plans (SAPs) including mock-up displays for tables, listings, and figures.
•Coordinate activities of biostatistics and statistical programming personnel on assigned projects.
•Create or review programming specifications for analysis datasets, tables, listings, and figures.
•Review SAS annotated CRFs, database design, and other study documentation.
•Conduct and participate in verification and quality control of project deliverables.
•Serve as biostatistics representative on project teams.
•Manage scheduling and time constraints across multiple projects.
•Monitor progress on study activities against milestones.
•Provide statistical programming support as needed.
•Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities.
•Lead projects involving integrated analyses and attend regulatory agency meetings.
•Follow applicable SOPs, WIs, and relevant regulatory guidelines.
•Maintain organized project documentation and verification/quality control documents.
•Support business development activities by contributing to proposals and budgets.
•Coach and mentor other Biostatistics staff.

Principal BiostatisticianMedical AffairsClinical TrialsBiostatisticsRWESASRemotePharmaceuticalBiotechnology

Key Responsibilities

•Provide statistical support to Medical Affairs group for exploratory analysis, observational studies, RWE, and publication support.

•Prepare Statistical Analysis Plans (SAPs) including mock-up displays for tables, listings, and figures.

•Coordinate activities of biostatistics and statistical programming personnel on assigned projects.

•Create or review programming specifications for analysis datasets, tables, listings, and figures.

•Review SAS annotated CRFs, database design, and other study documentation.

•Conduct and participate in verification and quality control of project deliverables.

•Serve as biostatistics representative on project teams.

•Manage scheduling and time constraints across multiple projects.

•Monitor progress on study activities against milestones.

•Provide statistical programming support as needed.

•Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities.

•Lead projects involving integrated analyses and attend regulatory agency meetings.

•Follow applicable SOPs, WIs, and relevant regulatory guidelines.

•Maintain organized project documentation and verification/quality control documents.

•Support business development activities by contributing to proposals and budgets.

•Coach and mentor other Biostatistics staff.