Senior Biostatistician
65.000 €EUSA Pharma
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
Offerta di lavoro pubblicata 14 ore fa
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