Description
A sought after Pharmaceutical Company in the Bay Area is hoping to expand its Biometrics team in the coming year. They are about to enter phase III for a global trial and are looking to release the drug in the next couple years. This is a mid-sized company in San Francisco, CA with strong financial backing and a promising pipeline. (Permanet, Onsite Position)The following provides a more detailed description of the role:
- Apply computer science and information technology methods to provide the technical components that support analysis, reporting, decision-making process, regulatory submissions, commercialisation and scientific utilisation data for the company products.
- Provide leadership to the delivery of components of technical programming and information for a project.
- Produce and maintain the technical database standards and Programming Specification documents
- Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM databases by these partners.
- Lead aspects of the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions under guidance
- Identify opportunities to improve the methodology and provide practical solutions for problems
- Contribute to the development of best practice to improve quality, efficiency and effectiveness
Position Requirements:
- MS/MA in Statistics or Biostatistics
- 4-5 years experience in the Pharmaceutical Industry as a Statistical Programmer
- At least 2 years experience using CDISC
- FDA submissions experience preferred
- Comfortable with creating CSR tables/listings/graphs
- Experience with adhoc analysis in an extreme timeframe
If interested in this position, please apply to receive further detail.
To find out more about Real please visit www.realstaffing.com