Biostatistician

InfoQuest Consulting Group Inc. - Monmouth Junction, NJ (30+ days ago)


Duration & Type:
4 months Contract with a major Pharma client

Location: Emeryville, California

Description:

The Biostatistician will be responsible for providing statistical consultation and advice in quantitative/statistical issues in support of R&D, manufacture, and quality operations of the company.

Responsibilities:
  • Review protocols and develop appropriate statistical design and analysis plan.
  • Write statistical analysis reports, document the work in compliance with policies and regulations.
  • Provide the necessary input for productive collaboration with R&D scientists and Quality organization.
  • Work with project teams to produce protocols, analysis plans and final reports for clinical and nonclinical projects.
  • Plan, coordinate and produce statistical analyses, summaries and write formal memoranda.
  • Produce SAS programming and other software package programming to analyze data.
  • Interpret the project implications of regulatory guidelines. Interact with FDA, other regulatory or auditing agencies as appropriate in statistical aspects of study design, data analysis, and justification of statistical procedures.
  • Represent Biostatistics on company-wide project teams. Serve as primary liaison between Biostatistics and key internal clients with regard to resource needs and timelines.
  • If appropriate, interact with counterparts at companies collaborating with other Teams including proactively engaging with joint development corporate partners.
  • Initiate methodological research in statistics to improve biostatistics methodology used in developing products consistent with corporate priorities and timelines.
  • Develop Clinical and Nonclinical Biostatistics procedures and guidelines to comply with corporate policies and procedures.
Required:
  • Must have proficiency as an SAS programmer.
  • Master’s degree in Statistics or Biostatistics with at least two years related experience
  • Minimum 2 years experience in Biostats role within Pharamceutiocal or Diagnostics industry.
  • Minimum 2 years Manufacturing and product development in Pharmaceutical/Biotechnology industry experience (assay validation, product specification setting, OOS, SPC, process optimization, etc.).
  • Minimum 2 years experience managing people in a Biostats or clinical capacity.
  • Demonstrated sound knowledge of statistical applications to clinical and nonclinical projects.
  • Demonstrated technical expertise across a range of commonly used statistical methodology.
  • Knowledge of appropriate regulations and guidance documents. Broad experience across a range of clinical and nonclinical projects and demonstrated support of diverse client needs.
  • Demonstrated management and leadership skills.
  • Demonstration of innovation by development or novel application of statistical methods.
  • Knowledge of FDA regulations and guidelines is a plus.
For consideration, please send resume to career@infoquestgroup.com