Associate Director, Pharmacology Statistician
Reporting into the Head of Clinical Pharmacology Statistics in the Specialty Clinical Development group of Teva, as the Associate Director, Pharmacology Statistician would be part of the team who is responsible for providing statistical leadership for overall program and individual study strategy. This role will allow you to demonstrate your leadership qualities, be creative and think strategically, all while playing a vital role with your knowledge of cutting-edge clinical trial design and methodology.
By participating in First in Human (FIH)/clinical pharmacology studies, supporting Teva’s global regulatory submissions, you will be responsible for the statistical aspects of the design, implementation and analysis. Working across multi-functional areas across the organization, you will determine the necessity and type of research that is required by providing strategic study design input and consultation for protocols. You will also have the ability to communicate results to your respected audiences.
You’ll also be responsible for:
- Conduct modeling and simulation independently, or in collaboration with Pharmacometrics, Translational Sciences, DMPK teams to assist drug development strategies
- Leading the efforts to select CROs for outsourcing of statistical activities
- Collaborate with outsourcing partners and oversees conduct of statistical aspects of outsourced studies
- Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives
- Consult, mentor, and teach other statisticians on statistical methodology, trial design, and data analysis
- Master’s degree in Statistics, Biostatistics or related field of study with 10+ years of experience in Clinical statistics
- PhD in Statistics, Biostatistics or related field of study with 6+ years of experience in Clinical statistics
- Experience in Clinical Pharmacology / FIH trials
- Experience with modeling and simulation, multiple comparisons, missing data analysis, Bayesian methods in addition to knowledge of fundamentals in statistics
- Experience with clinical development process, model informed drug discovery and development (MID3)