Pharmaceutical-Jobs in Kanada

The Position

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The Opportunity
As the Biostatistics Leader - Immunology, you will provide strategic leadership and oversight across all Biostatisticians within Immunology, 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, and 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 area-aligned Biostatistics TA Leaders.

In your role, you will drive excellence in Biostatistics in Immunology 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

1. 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.
2. 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.
3. 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.
4. 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.

1. Provide strategic leadership and oversight for the Immunology Biostatistics strategy, ensuring a consistent and high-quality approach in line with the global Biostatistics strategy.
2. 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 PD-DSA and company objectives.
3. Ensure that biostatistical considerations are integrated early in study designs and development programs, aligning with regulatory and scientific best practices.
4. 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.
5. Represent statistical expertise and excellence in therapy area-level governance/Development Boards to ensure scientific rigor in study design, analysis, and interpretation.
6. Evaluate challenges as they arise and direct them to the appropriate decision-makers for resolution.

1. 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.
2. Ensure seamless collaboration between Biostatistics and external partners, including regulatory agencies, academic institutions, and industry consortia.
3. 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 Immunology goals and delivering impactful results.
4. Represent Biostatistics at cross-functional meetings, regulatory interactions, and external collaborations.
5. Influence therapeutic area strategies by providing data-driven insights and recommendations.

1. Act as the single PD-DSA point of contact for the Immunology, overseeing data analysis and insights generation strategies.
2. 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.
3. 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.
4. 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.
5. Maintain and adhere to multi-modal standards and best practices for statistical methods and deliverables set by Real World and Clinical Data Strategy.

1. Lead, inspire, and develop a high-performing global team of biostatistics leaders, ensuring their continued professional growth and ability to drive strategic impact.
2. 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.
3. Provide feedback, recognition, and development on a continuous basis.
4. Promote a culture of accountability, innovation, and continuous learning within the team.
5. Partner with P&C and leadership to attract, retain, and develop top biostatistical talent to support long-term organizational success.

1. PhD, or other advanced degree in Statistics, Biostatistics, or Mathematics.
2. More than 10 years of 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.
3. 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.
4. 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.
5. Experience and understanding of the new trends with all relevant data types (e.g., high-dimensional data) and analytics.
6. Track record of establishing successful internal and external partnerships with relevant partner organizations and able to act as an ambassador for Roche.
7. Willingness to adopt new technologies and methodologies, deep interest in AI and digital advancements.
8. Influential and confident communicator.
9. Strong English language skills.
10. International travel as required - estimated at 20%.