The Statistical Scientist partners 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.
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
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.
Ph.D. in statistics or biostatistics with at least 2 years of experience or a master’s degree in statistics or biostatistics with at least 5 years of experience designing and analyzing clinical trials
Excellent understanding of theoretical and applied statistics.
Good knowledge and experience applying statistical methods to drug development
Experience with statistical software packages such as R, SAS, and JMP.
Excellent 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)
Evident Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)
Evident 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)
Ability to work independently on multiple projects.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
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