6 days ago

Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA) - Early Phase

Syneos Health

Netherlands

6 days ago

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Syneos Health is seeking a Senior/Principal Statistician for a sponsor-dedicated role, with many possible locations across EMEA. The role involves providing statistical support across the lifecycle of clinical trials, from protocol to CSR, including preparing SAPs, coordinating biostatistics activities, and ensuring quality deliverables. Requires a PhD/MS in statistics or related field with at least 3 years of pharmaceutical experience, advanced statistical knowledge, and proficiency in R.

RemoteFull-timeSeniorRSAS

Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA) - Early Phase

Apply

RemoteFull-timeSeniorR

Salary

Not specified

Work Location

Netherlands, NL

Work Model

Remote

Experience Required

3 years

Employment Type

Full-time

Experience Level

Senior/Principal

Core Qualifications

Technical (Must-have)

RSASStatistical Analysis Plans (SAPs)Clinical trial designEarly-phase clinical trialsICH guidelinesData Safety Monitoring BoardData Monitoring CommitteeRegulatory submissionsBiostatisticsStatistical programmingQuality controlProject managementMentoring

Soft Skills

CommunicationCollaborationProblem solvingLeadershipMentoringAdaptabilityTime managementAttention to detail

Key Responsibilities

•Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
•Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
•May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
•Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.
•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.
•Conducts and participates in verification and quality control of project deliverables.
•Implements company objectives, and create alternative solutions to address business and operational challenges.
•Serves as biostatistics representative on project teams.
•Manages scheduling and time constraints across multiple projects.
•Monitors progress on study activities against agreed upon milestones.
•Provides statistical programming support as needed.
•May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities.
•May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions.
•Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
•Maintains well organized, complete, and up-to-date project documentation.
•Displays willingness to work with others and assists with projects and initiatives as necessary.
•Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
•Coaches and mentors other Biostatistics staff.
•Performs other work-related duties as assigned.

BiostatisticsClinical TrialsEarly PhasePharmaceuticalRSASRemoteEMEASeniorPrincipal

Core Qualifications

Technical (Must-have)

Soft Skills

CommunicationCollaborationProblem solvingLeadershipMentoringAdaptabilityTime managementAttention to detail

Key Responsibilities

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

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

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

•Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.

•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.

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

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

•Serves as biostatistics representative on project teams.

•Manages scheduling and time constraints across multiple projects.

•Monitors progress on study activities against agreed upon milestones.

•Provides statistical programming support as needed.

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

•May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions.

•Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).

•Maintains well organized, complete, and up-to-date project documentation.

•Displays willingness to work with others and assists with projects and initiatives as necessary.

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

•Coaches and mentors other Biostatistics staff.

•Performs other work-related duties as assigned.