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The Principal Biostatistician leads components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and
regulatory submissions within the program, and is accountable for the statistical deliverables.

Main Responsibilities and Accountabilities:

Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.
Author the initial statistical analysis plan for clinical trials and regulatory submissions. Beaccountable for timely completion and quality of the statistical analysis plan.
Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
Be responsible for interpreting analysis results and ensuring reporting accuracy.
Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
Be accountable for the TFL/CDISC package for study report and regulatory submission.
Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations
Support or lead improvement initiatives within the department, organization and/or pharma industry

Education/Experience

PhD with 5 years of experience or MS with 8 years of experience in drug development
Experience providing statistical leadership at a study level

Strong experience in Phase II,III & IV

Late Phase / RWE experience is highly preferred

Demonstrated statistical contribution in facilitating and optimizing clinical development
Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
Experience supporting regulatory interactions or submissions preferred

Competencies

Broad knowledge of clinical development and processes
Ability to collaboratively work and provide leadership in matrix environment
Strong interpersonal and communication skills (verbal and written in English)
Strong working knowledge of SAS and/or R
Track record of innovation or expertise in statistical methodologies in the context of clinical development desired
Familiarity with relevant regulatory guidance documents
-Expertise in
-CDISC, statistical programming, and/or data standards
-Biostatistics and Statistical Programming Operations

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com