Emeryville, CA | Contract
Bayside Solutions is seeking a Biostatistician to be part of our Client’ s team in Emeryville. This is an opportunity to work with a Global healthcare company focusing on improving the health and well-being of people around the world.
Our client is a Global sponsor company that develops innovative diagnostic therapies designed for hospitals, laboratory professionals and healthcare providers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
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.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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.
- 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.
- 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 Pharmaceutical/Biotechnology industry experience (assay validation, product specification setting, OOS, SPC, process optimization, etc.).
- 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.
- 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.