Candidates with Bachelors or Masters degrees in statistics or biostatistics with clinical trials experience are encouraged to apply as well.
Biostatistics Job Descriptions 2005
Senior Biostatistician – E4
RESPONSIBILITIES: The Senior Biostatistician works with senior biostatistics staff and clinical monitors on clinical development plans; the design and conduct of clinical studies; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA.
As part of a development assessment team, collaborates in the preparation and review of the clinical development plan. For assigned clinical development projects, provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements. Reviews all project protocols, authors protocol statistical analysis sections, and generates study randomization. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops study analysis plans as a team member and leads this effort for selected studies. Develops statistical programs as necessary to perform analyses and prepare data displays. Authors results sections of the clinical study report. Supplies statistical input for BLA submissions and in response to FDA questions. Provides support for publication of clinical trial results. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
REQUIREMENTS: Ph.D. in Statistics/Biostatistics with at least 2 years of clinical trials.
Experience with statistical software packages such as SAS and S-Plus. Sound knowledge of theoretical and applied statistics. Sound understanding of regulatory guidelines in a pharmaceutical research setting. Effective skills in communication and team collaboration.
Senior Statistical Scientist – E5
RESPONSIBILITIES: Provides statistics leadership for clinical development projects and is directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies in the project. As part of a clinical development or assessment team, collaborates in the preparation and review of clinical assessments. Provides strategic input into the clinical development plan.
For assigned clinical development project(s), provides sound strategic, statistical and scientific input on project objectives, experimental design, and data analysis to meet project needs and FDA statistical and scientific requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Leads team’s development of study analysis plans. Assumes leadership for the Biostatistics activities related to portions of specific project(s).
Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. If a Biometrics Team Leader, plans and coordinates Biometrics team activities to ensure successful and timely completion of assigned projects. Authors statistical analysis results

in the clinical study report. Leads team members to author the report. Responsible for seeing the report through review process. Represents Genentech Biostatistics at FDA meetings. Responsible for statistical input to responses to FDA questions and for statistical content of presentations at
Advisory Committee Meetings. Assumes statistical responsibility for major segments of a project, e.g. integrated safety/efficacy section of a BLA/NDA. Provides support for investigator publications. Encourage and contribute to discussion and preparation of publications and lectures on biometrics issues in clinical trials, both inside and outside Genentech. Engages in research in statistics to improve clinical trial methodology used in the development of Genentech products consistent with corporate priorities and timelines.
REQUIREMENTS: Ph.D. in Statistics/Biostatistics with at least 6 years clinical trials experience.
Must have a comprehensive understanding of theoretical and applied statistics. Comprehensive understanding of regulatory guidelines in a pharmaceutical research setting; experience in clinical trials through at least one BLA/NDA. Ability to communicate effectively at all levels. Strong team contributor with effective leadership abilities.
Associate Director, Biostatistics – D1
Purpose: Leads a biostatistics group in support of clinical development for one or more therapeutic areas.
Job Description:
- Line management responsibility for a group of Biostatisticians in one or more therapeutic areas, including setting employee goals and doing performance reviews.
- Responsible for the statistical input provided by the group to all major documents, including clinical development plans, protocols, clinical study reports, summaries of clinical safety and efficacy, and other sections of BLAs.
- Advises Biostatisticians on technical issues associated with the design, performance, and analysis of clinical trials.
- Provides review and guidance to Biostatisticians on statistical aspects of all FDA interactions, including FDA meetings, responses to FDA questions, and Advisory Committee Meetings.
- Works closely with Therapeutic Area management in defining strategic approaches to clinical trials and in meeting operational requirements of development plans.
- Works closely with Biostatistics management to ensure a coordinated approach to Biostatistics work.
- Provides leadership to therapeutic area Biometrics management team.
- Maintains comprehensive knowledge of theoretical and applied statistics and regulatory guidelines regarding clinical trial analysis and reporting. Applies new statistical procedures to
Genentech projects as appropriate.
Job Qualifications:
- Ph. D. in statistics/biostatistics with at least 8 years experience; at least 2 years experience managing project statisticians
- Comprehensive understanding of theoretical and applied statistics; extensive experience in clinical trials.
- Comprehensive understanding of regulatory guidelines in a pharmaceutical research setting.
- BLA/NDA development and submission experience required.
- Ability to effectively collaborate, communicate, and influence throughout all levels of the organization.
- Strong leadership abilities

To be considered, please contact Nicole Walton at (650) 225-3715 or nwalton@gene.com.