1 week ago

Associate Biostatistics Director - FSP (Permanent Home-based)

IQVIA

Amsterdam

1 week ago

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Lead full scope of Biostatistics for clinical programs within a therapeutic area at IQVIA. Requires PhD/MS in Biostatistics and 8+ years of clinical trial statistics experience. Permanent home-based role in Amsterdam.

AI-enabledRemoteFull-timeSeniorSASR

Associate Biostatistics Director - FSP (Permanent Home-based)

Apply

AI-enabledRemoteFull-timeSeniorSAS

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

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 submissionsFDAEMAPMDA

Soft Skills

communicationcollaborationleadershipstrategic thinking

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 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 (e.g., 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.

BiostatisticsClinical TrialsRegulatory SubmissionsSASRAdaptive DesignsPharmaceuticalCRORemoteDirector

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 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 (e.g., 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.