Our client is a biotechnology company. They have asked us to assist them in their search for a Director, Biostatistics.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Utilizes modeling and simulation to improve study design and identifies opportunities to improve statistical methodology and/or provide practical solutions for problems.
- Ensures accurate and statistically valid deliverables.
- Effectively works with vendors in planning and delivery of outsourced statistical work.
- Conducts analyses of internal and external information to inform design decisions and the development of decision criteria.
- Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
- Develops study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells.
- Produces statistical analysis summary and analysis plans, including textual description of planned analysis and mockups of data displays.
- Interprets study results and provides reviews of statistical summary reports to study results.
- Plays a critical role in the development and review of the study synopsis, protocol statistical analysis plan, clinical study report, and other regulatory submission documents.
- Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
- Provides input to project timelines and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
- Contributes to the development of best practice to improve quality, efficiency, and effectiveness.
- A master’s degree or PhD in statistics or biostatistics or related field is required.
- Must have seven to ten years of experience in Biotechnology, Pharmaceutical or Healthcare industries.
- Prior experience providing statistical support to Phase I-IV clinical studies is required.
- Requires high-level expertise in statistical programming R or SAS or other statistical applied software systems.
- Experience in oversight of outsourced statistical work for clinical trials is preferred.
- Must understand GCP, ICH, and FDA guidelines and regulations applicable to conducting clinical research.
- Experience in using or sound understanding of the value of the Bayesian methods in scientific research is preferred.
- Experience in CNS drug development within a pharmaceutical or biotechnology company is preferred.
- The ability to synthesize results in graphic, oral, and written reports is required.
- Requires demonstrated strong verbal and written communication skills, including the ability to communicate effectively remotely.
- The demonstrated ability to work creatively and independently to carry out assignments of a complex nature is required.
- Must be comfortable working in a fast-paced and evolving company environment.
- Advanced skills with MS Office and Clinical Trial Management Systems are required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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