Scientific Director - Biostatistics
Core competencies, Responsibilities and Accountabilities:
- Provides collaborative leadership to other drug development scientists through consultation and mentoring.
- Oversees the delivery of analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs.
- Partner with other Quantitative Sciences (QS) functions, contributes to strategic long-term decision-making by CPML Senior Management.
- Participate in external activities to help shape the external drug research and development and regulatory environments.
- Play a central role in sharing the knowledge and aligning the strategy across all Statistics & Decision Sciences (SDS) support (Early/Late Development, Medical Affairs, and Real World Evidence) for technical/scientific aspects of a particular Disease/Functional Area.
- Demonstrate the ability to influence drug research & development strategic plans formulated with Senior Management stakeholders
- Ensure consistent approaches across compounds and in alignment with regulatory guidance as appropriate.
- Take an expert level lead in developing and applying strategic quantitative frameworks and scenario simulations to evaluate risk tolerance and options to optimize program and analysis strategies.
- Bridge scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
- Ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners and positively influencing decisions.
- Serves as a role model, and mentor to statisticians and other scientists. Takes a lead role in sharing statistical knowledge, within SDS and/or cross-functionally. Mentors’ junior colleagues in techniques, processes, and responsibilities.
Desired Skills and Experience
- Ph.D. in Statistics or related field with minimum 9 years relevant experience, or Master’s in Statistics or related field with a minimum of 11 years of relevant experience.
- Strong experience in regulatory activities (e.g. submissions, interactions) is required.
- Have an advanced understanding of drug development processes and programs
- Ability to work in a matrix organization and cross-functionally to identify and resolve issues
- Proficiency in SAS or R, as well as a working knowledge of other relevant computational tools
- Highly effective written, oral, and interpersonal communication skills
- Demonstrated statistical knowledge and expertise across multiple disease areas/targets within or across Therapeutic Areas (TAs)
- PhD preferred.
- Oncology TA knowledge and expertise is preferred
- Previous leadership experience is preferred