Senior Director, Clinical Biometrics & Analyst
Skills
About the role
Lead biostatistics and data management strategy for a global pharmaceutical company's clinical development portfolio, based in Parma, Italy (hybrid). This role suits experienced statistical leaders who want to influence drug development strategy while remaining scientifically engaged, overseeing about 30 statisticians and data managers and championing modern methodologies like Bayesian approaches. You'll guide statistical direction from early trials through regulatory approval, with emphasis on scientific leadership and technical innovation rather than day-to-day management.
What you’ll do
- Establish and execute biostatistics strategy across early and late-phase clinical programs
- Champion innovative statistical methodologies, including Bayesian methods and adaptive trial designs
- Oversee development of Statistical Analysis Plans and regulatory submission content
- Partner with Clinical Operations, Regulatory Affairs and Medical Affairs on study strategy
- Mentor and develop a team of approximately 30 statisticians and data managers
- Represent biostatistics in governance forums and regulatory interactions
What they’re looking for
- Master's degree or PhD in Biostatistics, Statistics, Mathematics or related quantitative field (PhD preferred)
- Substantial leadership experience in Biostatistics within pharmaceutical or biotechnology sectors
- Deep expertise supporting both early and late-stage clinical development
- Strong knowledge of innovative statistical methods, including Bayesian statistics and adaptive designs
- Understanding of GCP, ICH guidelines, CDISC standards and global regulatory expectations
- Proficiency in SAS and/or R programming
- Track record of influencing senior stakeholders through scientific expertise
- Experience building and managing high-performing global teams
Nice to have
- Experience in agile biotech or innovation-focused pharmaceutical environments
- Knowledge of Paediatric Investigation Plans (PIPs)
- Exposure to neonatal clinical development
What’s on offer
- Competitive salary and annual bonus
- Comprehensive benefits package
- Hybrid working model (approximately one week per month on-site)
- Opportunity to shape statistical direction of innovative global programs
- Exposure to cutting-edge methodologies including Bayesian approaches and adaptive designs
- Access to highly collaborative biostatistics team with strong staff retention
- Career progression in a people-first, sustainability-focused organization
Questions about this role
Is this role on-site or remote?
It's hybrid, based in Parma, Italy with approximately one week per month on-site.
What qualifications do I need?
You'll need an MSc or PhD in Biostatistics, Statistics, Mathematics or related quantitative field (PhD preferred), plus substantial leadership experience in biostatistics within pharma or biotech.
What programming languages are required?
Proficiency in SAS and/or R is required.
How much experience do I need?
The posting asks for significant leadership experience but does not specify years.
How much does this pay?
The posting lists it as a competitive salary with annual bonus and comprehensive benefits but does not state a specific figure.
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