A leading global Biopharma company dedicated to a one mission: to discover, expand, and deliver groundbreaking medicines targeted to helping millions of patients around the globe in disease areas such as oncology, cardiovascular, immunoscience and fibrosis and many more.
The Associate Director of Biostatistics will have responsibilities that include:
- Individually leads the development and execution of statistical aspects for multiple complex clinical trials, including support to study trial design, analysis preparation, analyze results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.
- Leads sections of filing activities.
- preform strong technical skills to address complex issues within a team.
- Assists GBS Lead in delivering regulatory questions and advisory committee preparations.
- Endorses protocols and analysis plans at Protocol Review Committee reviews and offers independent reviews.
- Participant in constant improvement initiatives.
- Demonstrates understanding outside of conventional statistical expertise in the clinical, regulatory and commercial fields and application within development teams.
- Successfully engages as a matrix team member on protocol or higher-level project teams to perform as a scientific and strategic partner in the drug development process.
- Being able to explain summary data and analyses to key stakeholders and review committees in a transparent, concise, and comprehensive manner that provide influence on vital development outcomes.
- Expert technical knowledge of statistical methodology that is properly applied in trial design and data analysis for clear, short, first-class results.
- Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
The Associate Director of Biostatistics will have the following skill set:
- PhD degree in statistics or biostatistics or master's degree with relevant experience required.
- 7+ years Pharmaceutical/R&D or other associated experience, including assisting regulatory filings.
- Experience organizing and preparing for regulatory meetings.
- Expertise in statistical / clinical trials methodology as it relates to clinical development.
- Capability to solve complex statistical problems.
- Extensive data analysis planning, execution and delivery experience including co-ordination across multiple protocols.
- Excellent verbal and written communications skills.
- Ability to be flexible and adapt quickly to the changing needs of the organization.
- Strong personal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to support in goal achievement.
- SAS knowledge
