Senior Biostatistician

Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Biostatistician for a Contract assignment with one of our premier Pharmaceutical Services clients in Pleasanton, CA.
Responsibilities :

• Provide statistical support for clinical trials and other functions such as research & development, quality, and marketing as needed.
• Interacts and consults with clinical and project teams to ascertain their needs and develop appropriate design and statistical solutions.
• Writes statistical analysis plans and reports for use by internal and external customers.
• Critiques and improves study designs developed across the organization.
• Has primary ownership of at least one major project and actively mentors less experienced colleagues as needed.
• Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.
• Writes statistical analysis plans as needed to capture design elements and statistical methodology.
• Performs statistical analyses and prepares statistical reports of results.
• Reviews statistical analyses conducted by statistical programmers and other biostatisticians to ensure accuracy and quality.
• Conducts randomization and blinding of samples.
• Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization.
• Maintains expertise in state-of-the-art data manipulation and statistical analyses, and mentors less experienced colleagues.
• Manages day-to-day operational aspects of a project.
• Monitors work to ensure quality

Required Skills:

• Master's Degree in Statistics or a related field is required
• 6 years minimum with Master's degree of relevant experience
• 3 years minimum with PhD degree of relevant experience
• Experience with SAS
• Knowledge of FDA guidelines for in vitro diagnostic devices and the required statistical basis for sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval.
• Strong ability to collaborate across departments and interact with various levels in the organization.
• High attention to detail with skill in producing organized reports.
• Ability to write statistical code and documentation.
• Ability to work in a team-focused environment.
• Ability to prioritize and plan work activities.
  

Preferred Skills:

• Ph.D. in Statistics or a related field is preferred.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com .

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