Sr Mgr Biostatistics
Bangalore, India, 566064
Who we are
The opportunity
The Senior Manager Clinical Statistician position is for a skilled statistician with training and experience in drug development and clinical research. He or she is expected to provide statistical support to clinical studies or programs within Teva Global R&D. The support includes, but not limited to, strategic planning, study designs, data analyses, and regulatory interactions. He or she is expected to have extensive knowledge about statistical principles and appropriate software and tools to perform his or her tasks. A Senior Manager Clinical Statistician should be a strong individual contributor and demonstrates leadership qualities with creative and strategic thinking. They must have excellent written and oral communication skills and demonstrate the ability to successfully working in a global environment.
How you’ll spend your day
- Primarily works at the Product/Program Level
- Provide input for budget planning
- Manage and Deliver assignments with quality and within timelines
- Possible to have direct reports; Possible to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources
- Responsible for statistical aspect of study designs and data analyses for clinical studies
- Provides study design input and consultation for clinical endpoint assessments and sample size planning
- Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with key stakeholders, as deemed necessary
- Writes, or oversees the writing of, statistical analysis plans
- Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts, and other documents to support the marketing of Teva products
- Leads the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses, and regulatory responses.
- Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate
- Proactively assesses and identifies processes that require improvement
- Participates in department initiatives to further the effectiveness of global statistics
- Implements innovative and cutting-edge clinical trial design, methodology and analysis
Your experience and qualifications
- Ph.D./MS in Statistics/Biostatistics (or related field)
- MS with a minimum of 10 years of related experience; PhD with a minimum of 6 years of related experience
- Proficiency in statistical programming languages (e.g., R, SAS) and experience with data visualization tools
- Regression modelling, Simulation, Adaptive trial designs, Bayesian statistics, Experimental design
Teva’s Equal Employment Opportunity Commitment