Principal Biostatistician
2 weeks ago
**Minimum Qualifications &Experience**:
Masters orPhD with a major is statistics/biostatistics or related field with > 10 years of pharmaceutical industry, CRO or related experience. Proficiency with Microsoft Office tools (e.g. Word and Excel) and standard statistical packages (SAS TM) is expected.
**Responsibilities**:
- Perform or supervise complex statistical analyses and create or provide input to statistical reports.
- Cooperate with other company departments to optimize global efficiency.
- Act as a pro-active advisor for all types of analysis during the proposal process as well as during the project life cycle.
- Define strategies and evaluate the statistical resources needed to meet the defined project goals.
- Coordinate Biostatistics related project activities for successful completion within given timelines and budget.
- Interact with internal and external clients with regard to data analysis, scope of work, and budget.
- Ensure compliance with applicable regulatory agency guidelines and Novotech
- SOP’s in study design, protocol development and all other statistical output.
- Perform protocol development, sample size calculation, protocol and CRF review.
- Write statistical sections of integrated reports.
- Review derived datasets and all types of statistical analysis deliverables.
- Develop complex analysis strategies and execute them using efficient programmingtechniques.
- Produce and provide expert input to analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
- Quality control of all kinds of statistical deliverables.
- Training/mentoring of junior members ofthe department.
- Representing Novotech at client meetings.
- Participation in industry forum (conferences, professional association committee work etc.) as a means of professional development as well as promotion of Novotech’s image in industry.
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