Senior Biostatistician Consultant
3 weeks ago
SENIOR BIOSTATISTICIAN – (1 OPENING)
12+ MONTHS RENEWABLE
Our client on the West Coast needs the support of a highly experienced Senior Biostatistician consultant to support the team for a 12+ month project. This consultant needs to be very independent, and they will be working under the direction of the Director of Biostatistics. This consultant must have specific expertise working in Rare Disease and experience interacting with Regulatory Authorities. They will be expected to oversee design, execution and interpretation of statistical analysis for rare diseases.
* PhD in Statistics/Biostatistics and 10+ years of lead statistics experience in the life science industry
* Must have significant expertise in the rare disease therapeutic area
* Rare disease submission approvals is a plus
* FDA submissions experience and interaction with regulatory agencies
* Strong SAS skills
* Excellent and clear communication skills
* Leads the design and planning of statistical methodologies for clinical trials including: Sample size and power calculations, Randomization, Data collection strategies/CRF review
* Review and/or development of protocol, statistical analysis plan and other related clinical study documents
* Consideration of unique characteristics of rare diseases and specific regulatory requirements
* Oversees implementation of statistical analyses, including data monitoring, programming and complex modeling
* Summarizes and interprets results and provides meaningful insights for decision making, risk assessment and regulatory submissions
Work will be performed remotely. Flexible on time zones.
Job Type: Contract
Pay: $63.13 - $80.00 per hour
Education:
* Doctorate (Preferred)
Experience:
* lead statistics: 10 years (Preferred)
* rare disease: 8 years (Preferred)
* FDA submissions: 8 years (Preferred)
Work Location: Remote
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