Description
Senior BiostatisticianA rapidly expanding and publicly traded biopharmaceutical company located in San Francisco is seeking a qualified, highly motivated individual for the position of Senior Biostatistician. This is an exciting opportunity to join a growing team in heading new innovative projects within the biotechnology field. Seeking to hire immediately if all qualifications are met.
Requirements:
- In-depth knowledge of study designs and statistical analysis conventions in oncology areas a plus
- 4 (Ph.D.) - 6 (M.S.) years of experience as a project biostatistician in the biotech/pharmaceutical industry or medical research.
- Experience with protocol development, clinical study reporting, ISS/ISE requirements, and regulatory 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 (e.g., CRO, Medivation's corporate partners) study 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.
- Understands and uses SAS as well as other statistical software packages. As needed, writes programs to select, retrieve, manipulate, edit, and analyze data
Education:
- Ph.D. or M.S. in statistics, biostatistics, or related field
Duties & Responsibilities but not limited to the following:
- Responsible for statistical aspects of assigned projects, including experimental design, protocol development, 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 a timely and compliant manner
- 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 data management staff in the design of study databases. As needed, reviews study database structures and data management project 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
- Prepares statistical summary reports as needed. Writes and/or reviews the statistical sections of protocols and clinical study reports. Reviews draft protocols and clinical study reports
- Documents and archives analysis and programming work to ensure a complete audit trail. Creates and maintains biostatistics files for each assigned project
- Establishes and maintains effective working relationships with vendors and project teams, including data management personnel, statistical programmers, clinical research personnel and corporate partners
- Participates in project meetings, including investigator meetings
- Provides statistical input for regulatory submissions. Responds to statistical questions raised by regulatory agencies and institutional review boards
If you're interested in applying for this position, please reply to this post immediately as we are looking to fill this position ASAP!
To find out more about Real please visit www.realstaffing.com