STATISTICIAN
Posted: 7/21/2010
Type: Contract
Length: 12 Months
Location: PA
Description
The Statistical Consultant position is for a skilled scientist with training and significant experience in statistics, drug development, and clinical research. This position will provide opportunities for independent and/or leadership contributions to clinical trials and drug development programs .
The Statistical Consultant 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 and senior statistical 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, and writing sections of clinical study reports and registration documents. 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 definition 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), or MS/MA with a minimum of 2 years of 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 proficiently using SAS
• Ability to write SAS programs to perform efficacy and safety analyses
• Knowledge of CDISC SDTM and ADaM
• Knowledge of relevant FDA and CHMP guidelines
• Experience with regulatory submissions in the US
• 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
To apply, please contact:
Email: job@orbisdata.com
