PRINCIPAL BIOSTATISTICIAN (FSP - PERMANENT HOMEBASED)

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.
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