Location: Rockville, MD

Apply Now

Position Summary

The Senior Consultant Statistician position is for a skilled scientist with training and experience in statistics, drug development, and clinical research. This position will provide opportunities for independent contributions to clinical trials and drug development programs conducted by Teva in the area of biogenerics / biosimilars. The Senior Consultant Statistician needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks. He or she is expected to work collegially and closely with clinical research staff to determine appropriate study designs, sample size estimates, and write appropriate sections of study protocols. The position is also responsible for writing statistical analysis plans, analyzing data, helping write manuscripts, and writing sections of clinical study reports and registration documents. The Senior Consultant Statistician is expected to attend regulatory and project meetings as appropriate to support company activities. He or she must have excellent written and oral communication skills.


Essential Functions:

• Responsible for statistical aspects of the design, implementation, and analysis of clinical studies to support global regulatory submissions. Works with multi-functional areas of organization to determine necessity and type of research required. Works with statistical programmers, clinical research, and other statisticians to plan, analyze, and report clinical study data. Communicates results to relevant audiences.
• Provides study design input and consultation for clinical research protocols and drug development plans
• Provides consultation on clinical endpoint assessments and sample size planning for clinical studies.
• Prepares statistical sections of clinical protocols in collaboration with clinical research.
• Works with Data Management and Clinical Research personnel to provide statistical input for CRF design.
• Ensures that data sets and their associated define files are prepared correctly and on time to support FDA submissions
• Conducts analyses to support abstracts, manuscripts and other documents to support product marketing

Requirements:

• Ph.D. in Statistics/Biostatistics (or related field) with at least 2 years of related experience or MS with at least 5 years of related experience is required.
• Good presentation and written communications skills.
• Ability to communicate with non-statisticians to interpret statistical findings
• Good organizational and problem-solving skills.
• Ability to program using SAS
• Knowledge of CDISC SDTM and ADaM
• Knowledge of relevant FDA and CHMP guidelines
• Experience with regulatory submissions in the US desirable
• Experience with regulatory submissions outside the US desirable
• Knowledge and understanding of therapeutic-specific regulatory guidelines and perspective is preferred.
• Knowledge of techniques for demonstrating non-inferiority and bioequivalence highly desirable
• Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications is preferred.