Sr Mgr Biostatistics

We Are Teva

The Opportunity

The Senior Manager Clinical Statistics position is for a skilled statistician with formal training in statistics and some 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 is not limited to, strategic planning, study designs, data analyses, and regulatory interactions with the guidance of a senior level GSD statistician. He or she is expected to have extensive knowledge about statistical principles and the ability to use appropriate software and tools to perform his or her tasks. A Senior Manager Clinical Statistician should begin to act as an independent individual contributor with respect to their assignments. They should begin to attain and exercise leadership qualities with the guidance of a senior level GSD statistician.  In addition, he/ she should exercise situational awareness as they begin creative and strategic thinking that is appropriate for their assignments. They must have excellent written and oral communication skills and demonstrate the ability to successfully work in a global environment. 

How You’ll Spend Your Day

• May begin to work at the Product/Program level assignments under the guidance of a senior GSD statistician.
• Independently take on responsibilities for delivering on assignments with quality and within timelines.
• May oversee contingent workers and/or vendors; may provide training to others.
• May take on responsibilities for statistical aspects of study designs (sample size planning, endpoint assessment, etc.) and data analyses with the guidance of a senior level GSD statistician.
• Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with their supervisor or a senior level GSD statistician.
• Writes or may oversee the writing of statistical analysis plans with an appropriate level of guidance.
• Support or may oversee the support of statistical analyses for the writing of clinical study reports, abstracts, manuscripts, and other documents for the marketing of Teva products
• Performs statistical analyses in line with the strategic plans for global regulatory submissions, such as briefing packages, integrated analyses, and regulatory responses.
• Collaborate with outsourcing partners and may oversee the statistical aspects of outsourced studies, as appropriate.
• Identifies processes that may require improvement and communicates this to GSD management in an appropriate manner.
• Participates in department initiatives to further the effectiveness of global statistics.
• Begins to evaluate and possibly implement innovative clinical trial design and analysis that are appropriate in adding value to the clinical development program.

Your Qualifications and Experience

• Ph.D./MS in Statistics/Biostatistics (or related field).
• MS with a minimum of 4 years of related experience; PhD with a minimum of 2 years of related experience.
• Provides independent statistical support to clinical studies with the guidance of senior level statisticians (i.e., Associate Director or higher). Provides sample size planning in accordance with the study design and analysis. May provide study design input and consultation for study endpoint assessment. Must exhibit situational awareness in considering innovative clinical trial design and analysis.
• Independent contributor to assigned studies under moderate supervision.
• Tackles difficult problems; Identifies possible solutions; and works with his/her supervisor for appropriate resolution. 
• May leads process development and improvement.
• Competent in the planning, analysis and reporting of clinical trials of moderate complexity.
• Ability to work in an outsourcing model (fully or functional outsourcing)
• Good organizational and problem-solving skills.
• Ability to program using SAS or JMP, knowledge of R is beneficial.
• Knowledge of relevant ICH, FDA and CHMP guidelines

How We’ll Take Care of You

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