People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
Biostatistician II USMA
You will be aligned therapeutically with cross-functional Medical Affairs teams to provide statistical and analytical leadership in the development and execution of medical strategies, plans and projects. Like other team members in Biostatistics, you will be responsible for the statistical integrity, adequacy and accuracy of pre-launch, launch and post-marketing clinical studies other investigations and assessments, including exploratory analyses. As such, you will be a standing member of the assigned Medical Team, may also lead Biostatistics teams, as well as participate in other cross-functional projects or working teams. Given the nature of their positions, statistical scientists also work closely with their counterparts in Pharmaceutical Development and potentially Pharmaceutical Research and Early Development to align clinical data and statistics across varying drug development phases. You will be expected to perform your responsibilities with increased expertise and independence. Where assigned, you will also act as Medical Affairs representatives in related review and decision-making forums or committees, including, where applicable, representing Biostatistics input and data in health authority meetings, presentations and communications. All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws,regulations, policies & procedures that govern our business. Key Accountabilities: • Contributing statistical and analytical direction, insights, recommendations and overall input into development and execution of 3- and 1-year medical strategies, plans, objectives and projects • Developing,implementing and overseeing timely, thorough, consistent, and quality execution of statistical analysis plans that support medical strategies, plans, projects and objectives and assure statistical integrity, adequacy and accuracy • Providing appropriate biostatistics inputs and direction for the assigned products into a variety of pre-launch, launch and post-marketing medical affairs activities • Identifying, recommending and undertaking exploratory analyses and statistical research that furthers the success of pre-launch, launch and post-marketing clinical trials and other studies and assessments • Participating in the ongoing development, refinement and enhancements of departmental methodologies and techniques for biostatistics research, analysis and reporting • As needed, representing U.S. Medical Affairs Biostatistics to global Roche partners and working collaboratively to coordinate and align statistical analysis plans and outcomes at the national and global levels • Staying informed and abreast of the external landscape as it relates to assigned molecules, products, and programs and the associated therapeutic area(s)
Who You Are
Qualifications: Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following knowledge, skills and abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. Years of experience listed below can be substituted with equivalent, relevant competency levels. • Ph.D.+2 years in Statistics/Biostatistics • 2 or more years of clinical trial experience • Sound knowledge of theoretical and applied statistics • Relevant therapeutic experience is a plus • Must demonstrate sound knowledge of Phase IV/post-marketing drug development (knowledge of or experience with Phase I – III drug development is preferred) • GCP (Good Clinical Practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient • Proven experience in the principles and techniques of data analysis, interpretation and clinical relevance • Sound understanding of regulatory guidelines for drug development • Proficient computer skills, including Microsoft Word, PowerPoint, and Excel. Proficient with SAS and related software packages · Working experience with real world data such as medical administrative data is a plus Skills/Abilities
Proven abilities to perform statistical scientist responsibilities with increasing expertise and independence
Has demonstrated, through past experience, abilities to competently manage the majority of biostatistics deliverables associated with assigned pre-launch, launch and/or post-marketing medical strategies, plans and tactics
Analytical and problem-solving capabilities and skills
In-depth knowledge of the multi-disciplinary functions involved in a drug development process, and can proactively integrate multiple perspectives into the post-marketing process for best end-results
Excellent project management skills
Strong interpersonal, verbal and writing communication and influencing skills
Proven track record of working highly effectively, efficiently and collaboratively with others
Proven experience and skills working with multidisciplinary teams
Proficient computer skills, including Microsoft Word, PowerPoint, and Excel
High-level of proficiency with SAS and related statistical software packages
Business travel, by air or car, is required for regular internal and external business meetings
A Job with Benefits Beyond the Benefits
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 below.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for over 40 years. Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.