Company: RBW Consulting
Location: San Francisco Bay Area
Closing Date: 13 Mar 17
Type: Full Time
Salary (£): Competitive
Come join the team to be part of the change, be a part of the growth and await the opportunities within.
This company has built a broad portfolio of both small and large molecule candidates with the hope and potential to address diseases of which have high medical needs. Currently, there are no approved therapies for these needs, but this company looks to change that.
Experienced Biostatistician with drive, ambition and a willingness to work independently with advanced technical and communication skills.
Working with and reporting to the Senior Director of Biostatistics.
This role involves working as a program statistical lead as well as providing biostatistical support on designs of projects and conduct of clinical studies and providing technical leadership.
Participate in the evaluation, interpretation and reporting of study results in regulatory submissions to FDA as well as other Regulatory agencies- performing statistical analysis and developing tracking systems for data quality assurance.
The candidate must manage the efforts across therapeutic areas and identify, improve and implement departmental standards, applications as well as processes and training.
Within this role, it is important to lead in product level tasks including regulatory interactions and filing, ensure statistical integrity and contribute strategically to the supporting projects from statistics perspective.
Working on study level tasks from a statistics perspective. This would include contributing in study design and sample size determination, reviewing statistics sections in the protocol, SAP and DMC charter.
Create and review study randomization files-. This will include developing TLG shell, specification reviews, CRFs and other study documentations.
Collaborate within biometrics teams as well as with cross-functional teams to reach product deliverables and timelines for statistical data analysis and reporting.
Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
Independently conduct analyses suggested by the data; Propose new statistical methodological approaches to improve the efficiency of study results
Contribute in developing standards and research in advanced statistical methodologies
Review regulatory documents or scientific publications
Advise and mentor junior team members
To find out more about this fantastic opportunity please contact Amanda Leslie at RBW Consulting.
At RBW Consulting LLP, every one of our consultants has the benefit of five years’ experience in helping Pharmaceutical Professionals find the jobs they are looking for in the industry.
With unrivalled industry knowledge and excellent links across the world, we would be delighted to speak with you about the role you are looking for.
Southdown House, 130a Western Road, Brighton BN1 2LA
|Tel:||01293 584 300|
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