1 week ago

Principal Biostatistician, FSP - Permanent Homebased (m/w/d)

IQVIA

Amsterdam

1 week ago

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Principal Biostatistician needed to serve as statistical lead for late-phase clinical trials, providing scientific oversight and hands-on statistical support. Requires advanced degree in Biostatistics or Statistics, proven independent study statistician experience in Phase II/III trials, and proficiency in SAS. Permanent homebased position with IQVIA.

RemoteFull-timePrincipalBiostatisticsStatistics

Principal Biostatistician, FSP - Permanent Homebased (m/w/d)

Apply

RemoteFull-timePrincipalBiostatistics

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Homebased

Employment Type

Full-time

Experience Level

Principal

Core Qualifications

Technical (Must-have)

BiostatisticsStatisticsSASStatistical Analysis Plans (SAPs)Sample size calculationsClinical trialsRegulatory submissionsClinical outcomes studiesCardiovascular eventsSymptomatic endpointsQuality-of-life measuresAdvanced statistical methodologies

Soft Skills

Statistical leadershipIndependent workingProactive communicationCross-functional collaborationInfluential explanationStrategic guidanceProblem-solving

Preferred Qualifications

Technical (Nice-to-have)

RCRM systemsCRO experiencePharmaceutical industry experienceHealth authority interaction

Key Responsibilities

•Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.
•Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.
•Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.
•Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross-functional partners, pharma statisticians, or from finalized protocols.
•Implement non-standard or advanced statistical methodologies.
•Perform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.
•Conduct sample size calculations using SAS or R, and justify design assumptions when engaging with clinical leadership.
•Work closely with statistical programmers, providing clear direction, reviewing outputs, and ensuring alignment between the SAP and programming deliverables.
•Contribute hands-on with SAS programming, including working with clinical datasets and performing analyses when needed.
•Actively participate in CTT meetings, offering statistical expertise and driving alignment across clinical, programming, data management, and medical writing partners.
•Proactively communicate with team members to anticipate needs, address issues, and ensure clarity on statistical approaches.
•Provide clear, influential explanations of statistical concepts to non-statistical stakeholders.

BiostatisticianClinical ResearchPharmaceuticalLate-phase trialsSASRemoteFull-timePrincipal level

Core Qualifications

Technical (Must-have)

Soft Skills

Statistical leadershipIndependent workingProactive communicationCross-functional collaborationInfluential explanationStrategic guidanceProblem-solving

Key Responsibilities

•Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.

•Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.

•Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.

•Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross-functional partners, pharma statisticians, or from finalized protocols.

•Implement non-standard or advanced statistical methodologies.

•Perform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.

•Conduct sample size calculations using SAS or R, and justify design assumptions when engaging with clinical leadership.

•Work closely with statistical programmers, providing clear direction, reviewing outputs, and ensuring alignment between the SAP and programming deliverables.

•Contribute hands-on with SAS programming, including working with clinical datasets and performing analyses when needed.

•Actively participate in CTT meetings, offering statistical expertise and driving alignment across clinical, programming, data management, and medical writing partners.

•Proactively communicate with team members to anticipate needs, address issues, and ensure clarity on statistical approaches.

•Provide clear, influential explanations of statistical concepts to non-statistical stakeholders.