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| Employer Name: |
SpiderID: 2875793 |
| Location: PaloAlto, California |
Date Posted: 9/2/2009 |
| Wage: |
Category: Biotech |
| Job Code: A121 |
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| Number Of Openings: 2 |
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Job Description:
Principal Duties and Responsibilities
• Responsible for statistical aspects of assigned projects, including experimental design, sample size estimation, patient randomization, case report form design, statistical analyses, and presentation of data.
• Ensures that project-related biostatistics and programming work is carried out in accordance with SOPs. Develops study specific procedures (SSPs) for assigned projects as required and ensures that project team members adhere to the SSPs.
• Coordinates and reviews activities of biostatisticians and statistical programmers working on assigned projects.
• Directs and conducts statistical analyses and interprets results of analyses for assigned studies. Maintains consistent analytical approaches and reporting formats within and across studies.
• Assists clinical database administrators in the design of study databases. As needed, reviews study database structures and data management coding conventions. Reviews and, when necessary, writes quality control specifications for projects.
• Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
• Understands and uses SAS as well as other statistical software packages. As needed, writes programs to select, retrieve, manipulate, edit, and analyze data.
• Responsible for the accuracy and completeness of statistical analyses conducted for assigned projects. Researches and applies new statistical procedures as needed Monitors and when needed verifies statistical analysis programs written by biostatisticians and statistical programmers.
• Projects statistical and programming resource requirements needed to meet project timelines.
• Prepares statistical summary reports as needed. Writes and/or reviews the statistical sections of clinical study reports. Reviews draft clinical study reports.
• Documents and archives analysis and programming work to ensure a complete audit trail. Participates in the setting of project documentation standards. Creates and maintains biostatistics files for each assigned project.
• Establishes and maintains effective working relationships with vendors and project team members, including data management personnel, statistical programmers, and clinical research personnel.
• Participates as needed in project meetings, including investigator meetings.
• Provides statistical input for regulatory submissions. Responds to statistical questions raised by regulatory agencies.
Job Requirements:
Qualifications
• Senior Biostatistician I: Ph.D. or M.S. in statistics, biostatistics, or related field with at least 4 (Ph.D.) - 6 (M.S.) years of project biostatistician experience in the biotech/pharmaceutical industry.
• Senior Biostatistician II: Ph.D. or M.S. in statistics, biostatistics, or related field with at least 6 (Ph.D.) - 8 (M.S.) years of project biostatistician experience in the biotech/pharmaceutical industry. Must have an in-depth knowledge of study designs and statistical analysis conventions in two or more therapeutic areas.
• Experience with clinical study reporting, ISS/ISE requirements, and NDA submissions in paper and electronic format is essential.
• Excellent verbal and written communication skills are required.
• Comprehensive knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS, are a must.
• Able to collaborate effectively with internal and external study management teams to meet project timelines.
• Must be able to translate clinical study designs into statistical practice and educate study team members in the use of statistics
• Good interpersonal and project management skills are important.
Job Criteria:
Start Date: ASAP
Position Type: Contractor
Years of Experience Required: 6
Education Required: Masters
Overnight Travel: None
Vacation Time:
Contact Information:
| Contact Name: andrew thomas |
Company Type: Recruiter |
| Company: RHG |
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| City: Palo Alto |
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| State: California |
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| Zip: 94301 |
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