Oakland-Fremont-Pleasanton Metro Area, California
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.
EDUCATION / EXPERIENCE:
- Master's degree in Statistics or Biostatistics with at least two years related experience
- Minimum 2 years experience in Biostats role within Pharmaceutical or Diagnostics industry.
- Minimum 2 years Manufacturing and product development 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.
- Skilled SAS programming knowledge.
- Demonstration of innovation by development or novel application of statistical methods.
- Review protocols and develop appropriate statistical design and analysis plan.
- Build SAS program code and analyze data 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.
- Continue to develop professional and technical expertise.
- Perform additional responsibilities as necessary and/or assigned.
- Sound knowledge of theoretical statistics and statistical applications
- Must have proficiency as an SAS programmer
- Knowledge of FDA regulations and guidelines is a plus.
- Good communication and presentation skills.
- Ability to work effectively in both in a team environment and independently.
- Ability to work on several projects simultaneously.
- Possess good problem solving skills.
- Capable of addressing unique problems
- Experience in the diagnostics area is preferred.
- Developing consultation skills that include design, and data management issues for clinical and nonclinical projects.
- 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 development products consistent with corporate priorities and timelines.
- Develop Clinical and Nonclinical Biostatistics procedures and guidelines to comply with corporate policies and procedures.