Description
Position Summary:Key leadership partner in planning the design and data collection and analysis for clinical and non-clinical programs.
Manage and direct the company's biometrics activities; supervises the direction of internal and/or external data management and SAS programming efforts.
Essential Functions:
- Critical scientific thinking
- Designs, coordinates and implement statistical plans for Achaogen clinical programs
- Composes statistical methods sections of protocols and study synopses, including articulation of primary & secondary endpoints and power & sample size estimation.
- Works with Development staff to ensure that clinical trial designs are statistically sound.
- Works with statistical consultants to develop statistical strategies.
- Creates/supervises the completion of analytical plans for pertinent clinical programs.
- Performs/supervises primary analyses of clinical trial results and assist in their interpretation.
- Directs the activities of internal and/or external statisticians, SAS programmers, and data managers as they pertain to the above responsibilities.
- Facilitates selection of Biometrics CROs, directs Biometrics CRO efforts, as needed
- Develops and works within department budget
- Assists non-clinical scientists with study design/study analysis
Preferred Experience:
- Minimum of 5 years relevant experience in the pharmaceutical or biotechnology industry.
- Demonstrated evidence of success in the design and analysis of clinical trials
- Relevant involvement in regulatory filing / approval of NDAs / BLAs or equivalent
- Experience preparing analysis programs for clinical trials phases I-III.
- Familiarity with integration and analysis of biomarkers and companion diagnostics in clinical programs
- Must have sound knowledge of statistical applications for clinical trials and SAS programming.
- Must have first-hand knowledge of data processing and management, including data capture systems, statistical programming and report table generation.
- Demonstrated familiarity with non-clinical experiments: statistical considerations, design, and analysis
- Knowledge of infectious disease clinical trials design is a plus.
Preferred Education:
- Ph.D. in Biostatistics preferred; M.S./M.A. is minimum
- SAS, StatXact, power/sample size packages
- Strong leadership and management skills
- Excellent written and verbal skills.
- Proficient at programming skills.
- Excellent teamwork and collaboration skills
- Independent, innovative, and creative thinker
- Expert knowledge of scientific principles and concepts
- Ability to multi-task in a start up environment
To find out more about Real, please visit www.realstaffing.com