Senior Biostatistician

2 giorni fa

Milan, Lombardy, Italia EUSA Pharma Tempo pieno

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Overview

In this role you provide expert statistical leadership across development programs, shaping statistical strategy and ensuring rigorous analysis of data from clinical studies and related analyses. You will work with cross-functional teams to translate questions into evidence plans, support regulatory readiness, and maintain high statistical standards. The position offers impact through partnering with clinical, medical writing, and quality functions to ensure robust, reproducible findings. You will lead analyses and oversee CRO and internal programming to deliver clear insights that inform decisions.

Retribuzione / Benefits

competitive remuneration
salary starting from 65,000
comprehensive rewards package
local pay transparency compliance
internal equity considerations
remuneration discussions during recruiting process

Responsabilità

Define robust statistical approaches with Therapeutic Area management and translate questions into evidence plans
Provide statistical direction on cross-functional Project Teams and support evidence-based development decisions
Contribute high-quality statistical input to CVDs such as clinical development plans, protocols, and study reports
Partner with Medical Writing and other functions for scientific clarity, consistency, and regulatory readiness
Lead or supervise development of statistical analysis plans and production of tables, figures, and listings
Review study protocols and data management documents to ensure quality and consistency
Lead complex analyses and interpret results from clinical studies and meta-analyses and communicate implications to stakeholders
Maintain hands-on SAS expertise to perform or critically review analyses and oversee programming
Build partnerships with Medical and Clinical functions to plan analyses and resolve methodological questions
Partner with R&D Quality Assurance on audits of CROs and study sites to ensure data integrity
Collaborate with Drug Safety on pharmacovigilance data analyses
Contribute to development and maintenance of divisional SOPs, standards, and guidelines
Provide risk-based oversight of CRO deliverables and manage timelines and issues
Champion adoption of new statistical methods and tools to raise overall practices

Requisiti fondamentali

Advanced degree in Statistics, Biostatistics, Mathematics or a closely related quantitative discipline; PhD advantageous but not essential
Typically 10+ years of progressive biostatistics experience in pharma, biotech, or CRO with substantial responsibility for clinical development programmes
Deep expertise in theoretical and applied statistics and strong command of regulatory expectations in pharmaceutical development
Significant experience contributing to major regulatory submissions (NDA, MAA or equivalent) and responding to health authority questions
Credible and collaborative senior professional
Clear and influential communication of complex concepts
Autonomy with sound judgement in ambiguity
GCP
CDISC standards
regulatory guidance familiarity

Senior Biostatistician

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