Principal Statistician Oncology with Submission Experience

Syneos Health

Amsterdam

1 week ago

Amsterdam

1 week ago

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Principal Statistician Oncology with Submission Experience

Principal Statistician with oncology and submission experience needed at Syneos Health to lead biostatistics activities for clinical trials, oversee statistical analysis plans, and mentor team members. Requires graduate degree in biostatistics, extensive clinical trial experience, and proficiency in SAS/R.

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Remote

Full-time

Principal

SAS

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

8 years

Employment Type

Full-time

Experience Level

Principal (6 to 8 years)

Core Qualifications

Technical (Must-have)

SASRStatistical Analysis PlansRegulatory guidelines (ICH)DSMB/DMCClinical trials

Soft Skills

Written communicationVerbal communicationMentoringProblem solvingTeamwork

Tools (Must-have)

SASR

Preferred Qualifications

Technical (Nice-to-have)

Regulatory submissions

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/R 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.
•As biostatistics representative on project teams, interfaces with other departmental project team representatives.
•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.
•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.
•Maintains well organized, complete, and up-to-date project documentation and verification/quality control documents.
•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.

BiostatisticsOncologyClinical TrialsSASRRegulatory SubmissionsStatistical AnalysisDSMBPharmaceuticalPrincipal Statistician

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/R 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.

•As biostatistics representative on project teams, interfaces with other departmental project team representatives.

•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.

•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.

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

•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.