Sr Mgr Biostatistics

Job Description:

Responsibilities

• 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.

Qualification & Expeirence

• 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.