Reports To: Senior Director, Biometrics
This position oversees statistical aspects of assigned projects and provides support in study design, statistical analysis, and reporting of data. Plans, organizes, coordinates, and reviews biostatistics activities for assigned projects. Coordinates activities with other functional groups to ensure timeliness and quality of project deliverables. This position reports to the Senior Director, Biometrics.
Essential functions include but are 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.
- Ph.D. or M.S. in statistics, biostatistics, or related field with at least 4 (Ph.D.) – 6 (M.S.) years of experience as a project biostatistician in the biotech/pharmaceutical industry. In-depth knowledge of study designs and statistical analysis conventions in oncology and CNS therapeutic areas a plus.
- 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, is 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.
- Good interpersonal and project management skills are essential.
Human Resources
Medivation, Inc.
201 Spear Street
3rd Floor
San Francisco, CA 94105
hr@medivation.com
