2 days ago

Associate Biostatistics Director - FSP (Permanent Home-based)

IQVIA

Amsterdam

2 days ago

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Lead Biostatistics conduct for clinical programs within a therapeutic area at IQVIA, a global clinical research services provider. Define statistical strategy, ensure appropriate methodologies for study design and data analysis, and represent Biostatistics in regulatory interactions. Requires PhD or MS in Biostatistics/Statistics, 8+ years of clinical trial statistics experience, and advanced proficiency in SAS/R.

AI-enabledHybridFull-timeSeniorSASR

Associate Biostatistics Director - FSP (Permanent Home-based)

Apply

AI-enabledHybridFull-timeSeniorSAS

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Hybrid

Experience Required

8 years

Employment Type

Full-time

Experience Level

Minimum of 8 years of experience in clinical trial statistics

Core Qualifications

Technical (Must-have)

SASRBayesian methodsPredictive modelingSimulation techniquesAdaptive designsSample size calculationsInterim analysis planningStatistical analysis plans (SAP)Regulatory submissionsFDAEMAPMDAClinical development strategyGo/No-Go criteria

Soft Skills

CommunicationCollaborationLeadership

Preferred Qualifications

Technical (Nice-to-have)

Interactions with major regulatory authorities

Key Responsibilities

•Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
•Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
•Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
•Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
•Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
•Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
•Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).
•Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
•Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.

BiostatisticsClinical TrialsRegulatory AffairsSASRBayesian MethodsAdaptive DesignsPharmaceuticalCRODirector

Core Qualifications

Technical (Must-have)

Soft Skills

CommunicationCollaborationLeadership

Key Responsibilities

•Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.

•Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.

•Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.

•Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.

•Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.

•Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.

•Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).

•Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.

•Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.