Senior Biostatistician Consultant

2 weeks ago


Remote, United States Redbock Full time
Redbock is a specialized life science consulting firm that provides unique opportunities to candidates in the medical device, pharmaceutical, and biotechnology industries. We take the time to understand what both our clients and candidates are seeking, and work very hard to ensure we are providing everyone involved with an excellent level or service. We offer competitive pay, medical benefits, a 401k, as well as additional benefits to our Consultants.

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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