Biostatistics Leader - Immunology

The Position

We advance science so that we all have more time with the people we love.

The Opportunity

As the Biostatistics Leader Immunology you will provide strategic leadership and oversight across all Biostatisticians within Immunology ensuring a cohesive and highperforming subfunction 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 Immunology area in their delivery against the portfolio. Your role will be instrumental in informing clinical design in partnership with all therapeutic areaaligned Biostatistics TA Leaders.

In your role you will drive excellence in Biostatistics in Immunology by partnering crossfunctionally across PD Data Sciences & Analytics (PDDSA) 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 crossfunctional enterprisewide or external initiatives that shape our technical business and healthcare environments.

You will lead a global highperforming organization of approximately 2050 Biostatistians to support the unique demands of latestage 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 latestage development programs at Roche.

PDDSA SHARED LEADERSHIP OBJECTIVES

• Develop and set a clear PDDSA strategy and goals that align with Roches broader objectives ensuring that you integrate Roches One Pharma strategy PD goals and R&D Excellence methods into the strategic direction

• Embed and drive the adoption of PDDSAs 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 lockstep with your colleagues and partners to maintain alignment and drive crossfunctional collaboration

Leadership and Strategy

• Provide strategic leadership and oversight for the Immunology Biostatistics strategy ensuring a consistent and highquality approach to in line with the global Biostatistics strategy

• Develop and implement a comprehensive set of strategic objectives with nuances for Immunology to be included as part of the global Biostatistics strategy ensuring alignment with PDDSA 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 PDDSA clinical development regulatory affairs and data science teams to shape the future of statistical contributions within Roche

• Represent statistical expertise and excellence in therapy arealevel governance / Development Boards to ensure scientific rigor in study design analysis and interpretation

• Evaluate challenges as they arise and direct them to the appropriate decisionmakers 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 . You will influence crossfunctional teams to stay at the forefront of industry advancements while ensuring alignment with Immunology goals and delivering impactful results

• Represent Biostatistics at crossfunctional meetings regulatory interactions and external collaborations

• Influence therapeutic area strategies by providing datadriven insights and recommendations

Technical Biostatistics Accountability

• Act as the single PDDSA point of contact for the Immunology overseeing data analysis and insights generation strategies

• Ensuring scientific rigor in all data analyses and interpretations driving excellence across all data types to deliver actionable insights and support informed decisionmaking 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 Immunology while ensuring excellence in statistical contributions and the analysis and interpretation of all data types

• Maintain and adhere to mulitmodal standards and best practices for statistical methods and deliverables set by Real World and Clinical Data Strategy

Team Development

• Lead inspire and develop a highperforming global team of biostatistics leaders ensuring their continued professional growth and ability to drive strategic impact

• Establish and track performance metrics for the teams 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 longterm 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 TAenabling strategy. Ability to consult and understand medical issues

• Indepth knowledge of GCP international and incountry regulations guidelines and their application and all other applicable compliance standards related to data and statistical sciences and industry conventions

• Thorough understanding of the endtoend 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. highdimensional 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 $250800.00 $465800.00 USD Annual. Actual pay will be determined based on experience qualifications geographic location and other jobrelated 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.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

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