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The Opportunity
As the Biostatistics Leader, Ophthalmology, you will provide strategic leadership and oversight across all Biostatisticians within Ophthalmology, ensuring a cohesive and high-performing sub-function that drives excellence in service of our larger global Biostatistics strategy through study design, data analysis, and insights generation. You will report to the Global Head of Biostatistics, you will be responsible for leading and ensuring the overall performance of the Biostatistic team serving the Ophthalmology area in their delivery against the portfolio. Your role will be instrumental in informing clinical design, in partnership with all therapeutic area-aligned Biostatistics TA Leaders.
In your role, you will drive excellence in Biostatistics in Ophthalmology by partnering cross-functionally across PD Data Sciences & Analytics (PD-DSA) to support portfolio delivery. You will also partner closely with other Biostatistics TA Leaders on common issues that impact all therapeutic areas and / or Biostatistics teams at Roche. You will leverage the strengths of a global team and create an inspiring environment where you and your team feel empowered, take ownership of work, knowledge and resources and strive for continuous improvement. You will establish and foster key internal and external relationships, purposefully collaborating to be at the forefront of our industry. You may also contribute to, develop and lead functional, cross-functional, enterprise-wide or external initiatives that shape our technical, business and healthcare environments.
You will lead a global, high-performing organization of approximately 20-50 Biostatistians to support the unique demands of late-stage development within your therapeutic area. Your direct reports will be a team of directors and above. Reporting to the Global Head of Biostatistics, you will have a direct line to influence and contribute to the overall strategy and success of late-stage development programs at Roche.
PD-DSA SHARED LEADERSHIP OBJECTIVES
Develop and set a clear PD-DSA strategy and goals that align with Roche’s broader objectives, ensuring that you integrate Roche’s One Pharma strategy, PD goals, and R&D Excellence methods into the strategic direction
Embed and drive the adoption of PD-DSA’s strategic imperatives of Data, Digital/AI, and Design (the 3Ds) across your teams’ workflows, taking ownership of this mindset shift to ensure a seamless integration of these principles into daily operations
Act as a role model for your teams by delivering excellence in all aspects of your work (what you do, how you do it, and the impact you have), fostering a culture of learning, growth, and continuous improvement that empowers team members to reach their potential
Define and create clear accountability across each function in your organization and beyond, ensuring that you work in lock-step with your colleagues and partners to maintain alignment and drive cross-functional collaboration
Leadership and Strategy
Provide strategic leadership and oversight for the Ophthalmology Biostatistics strategy, ensuring a consistent and high-quality approach to in line with the global Biostatistics strategy
Develop and implement a comprehensive set of strategic objectives with nuances for Ophthalmology to be included as part of the global Biostatistics strategy, ensuring alignment with PD-DSA and company objectives
Ensure that biostatistical considerations are integrated early in study designs and development programs, aligning with regulatory and scientific best practices
Partner closely with senior leadership across PD-DSA, clinical development, regulatory affairs, and data science teams to shape the future of statistical contributions within Roche
Represent statistical expertise and excellence in therapy area-level governance / Development Boards to ensure scientific rigor in study design, analysis, and interpretation
Evaluate challenges as they arise and direct them to the appropriate decision-makers for resolution
Stakeholder Engagement and Partnerships
Act as the primary liaison between the Biostatistics function and key stakeholders across Clinical, Regulatory, and Data Science teams to drive alignment and shape outcomes for shared objectives with specific therapeutic area relevance
Ensure seamless collaboration between Biostatistics and external partners, including regulatory agencies, academic institutions, and industry consortia
Establish and foster key internal and external partnerships, purposefully collaborating with clinical teams on study design, data strategies, and execution. You will influence cross-functional teams to stay at the forefront of industry advancements while ensuring alignment with Ophthalmology goals and delivering impactful results
Represent Biostatistics at cross-functional meetings, regulatory interactions, and external collaborations
Influence therapeutic area strategies by providing data-driven insights and recommendations
Technical Biostatistics Accountability
Act as the single PD-DSA point of contact for the Ophthalmology, overseeing data analysis and insights generation strategies
Ensuring scientific rigor in all data analyses and interpretations, driving execution excellence across all data types to deliver actionable insights and support informed decision-making within the therapeutic area
Foster an adaptable environment of continuous learning that embraces advancements in digital & AI technologies, supporting the evolution of analytical tools and methodologies. Leverage modern AI capabilities to inform study design and statistical approaches. You will contribute your expertise in current and emerging technologies, data science trends, data flow and system interactions, ensuring continuous adoption of best practices and process improvements to enable the core biometrics functions
Be accountable for data analysis, insights generation strategy as well as data interpretation for Ophthalmology, while ensuring excellence in statistical contributions and the analysis and interpretation of all data types
Maintain and adhere to mulit-modal standards and best practices for statistical methods and deliverables set by Real World and Clinical Data Strategy
Team Development
Lead, inspire, and develop a high-performing global team of biostatistics leaders, ensuring their continued professional growth and ability to drive strategic impact
Establish and track performance metrics for the team’s overall success, ensuring alignment with organizational goals and driving continuous improvement, while providing professional development opportunities for team members
Provide feedback, recognition and development on a continuous basis
Promote a culture of accountability, innovation, and continuous learning within the team
Partner with P&C and leadership to attract, retain, and develop top biostatistical talent to support long-term organizational success
Who You Are
PhD, or other advanced degree in Statistics, Biostatistics, or Mathematics
More than 10 years experience (significant experience working at a senior level) in the pharmaceutical/biotech industry with an emphasis in TA and TA-enabling strategy. Ability to consult and understand medical issues
In-depth knowledge of GCP, international and in-country regulations, guidelines and their application, and all other applicable compliance standards related to data and statistical sciences and industry conventions
Thorough understanding of the end-to-end drug development lifecycle, particularly on elements involving data and statistical sciences, advanced analytics methods and data visualization tools and techniques
Experience and understanding the new trends with all relevant data types (e.g., high-dimensional data) and analytics
Track record of establishing successful internal and external partnerships with relevant partner organizations and able to act as an ambassador for Roche
Willingness to adopt new technologies and methodologies, deep interest in AI and digital advancements
Influential and confident communicator
Strong English language skills
International travel as required - estimated at 20%
Relocation benefits are available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $250,800.00 - $465,800.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
