Statistical Scientist- Clinical Development and Personalized Healthcare - Genentech
paid / South San Francisco, CA, USA / full-time
Genentech Biostatistics seeks talented and self-motivated statisticians to support clinical development activities and Personalized Health Care (PHC) projects in either early or late stage of clinical development. Our statisticians work as full members and key partners of multi-disciplinary teams to provide statistical and analytical leadership. We combine our expertise in applied statistics with our business knowledge to define and solve the right problems and to provide strategic input to maximize business impact. Teamwork and effective communication are essential. Candidates should be experienced in data analysis and expect to pursue projects involving statistical applications to molecular data for clinical development.
The statistician supporting late stage development will partner with senior scientists in biostatistics, clinical, safety, epidemiology, regulatory, research, and manufacturing on clinical development projects, research applications, development science applications, and/or product manufacturing applications. This typically includes partnering with senior scientists in the creation of strategies to address drug development needs and designing experiments, and evaluating and preparing study results for health authorities and the medical/research community. For clinical development programs, the Statistical Scientist typically is the lead Biostatistics representative on cross-development global clinical study teams.
The statistician supporting early development splits their time between molecule and non-molecule projects. For molecule projects, they will partner with senior scientists in biostatistics, clinical, safety, epidemiology, regulatory, research, and manufacturing on clinical development projects, research applications, development science applications, and/or product manufacturing applications. This typically includes partnering with senior scientists in the creation of strategies to address drug development needs and designing experiments, and evaluating and preparing study results for health authorities and the medical/research community. For early development programs, the Statistical Scientist typically is the lead Biostatistics representative on cross-functional development, clinical and execution teams. For non-molecule projects, they are expected to have expertise and interest in a variety of data types including in genomics, imaging, and digital health data or related fields to support clinical development and personalized health care activities, including collaboration with research and biomarker scientists, computational biologists and computer scientists.
Job description (the statistician will either support early or late stage development):
Late Stage Clinical Development:
- Member of clinical team, collaborating in preparation of Clinical Development Plans and target product profiles; typically lead statistician on cross-functional study management teams or sole statistician on early development project teams
- Study Planning: Reviews study protocols, authors statistical sections of protocols, prepares the study randomization, develops the statistical and data analysis plans, develops independent data monitoring and endpoint committee charters
- Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, review and approve analyses produced by statistical programming.
- Analysis & Reporting: Authors the clinical study report, provides input into global health authority documents and regulatory response for health authority submissions. Contributes to study publications and presentations. Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
- Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
- Participates in health authority meetings
Early Stage Clinical Development and Personalized Health Care (PHC):
- Serves as Biostatistics representative on clinical development teams, partners with cross-functional members and provides statistical and strategic input on clinical development plans.
- Looks beyond the statistical aspects, collaborating actively to promote rigor in the planning, conduct, analysis, interpretation and reporting of clinical and nonclinical experiments to meet project objectives, including clinical pharmacology trials and exploratory project activities such as biomarkers and PK/PD analysis.
- Provides strategic and analytic support for internal review and decision making.
- Collaborates with research, biomarker and computational scientists on personalized health care projects including in support of clinical development projects, disease areas and presentations/publications.
- Consults and provides statistical training to key stakeholders.
- Understand and apply business requirements and processes. Participates in functional training.
- Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
- Contributes to the biostatistics/scientific community by partnering with senior staff, mentoring junior colleagues, and participating in internal/external initiatives.
Job Qualifications: (Job level will be matched according to candidate’s experiences.)
- Ph.D. or MSc in statistics or biostatistics or related fields
- Good knowledge of theoretical and applied statistics including methods in advanced analytics
- Very good knowledge and experience applying statistical methods to drug development
- Good understanding of regulatory guidelines in a pharmaceutical research setting
- Understands and applies business requirements and processes
- Understands and respects cultural differences when interacting with colleagues in the global work place
- Accomplishes responsibilities with little supervision
- Effective Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)
- Good Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)
- Good Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects)
- Evident Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)
- Effective mentoring other statisticians
- Experience with all data types including high dimensional data
Apply: Via Genentech WorkDay