The Head of Clinical Analytics for Data & Analytics (D&A) is accountable to the scientific and strategic analytical direction and delivery of the Clinical Development portfolio goals in partnership with the cross-functional Development leaders. This role will drive the goals for Clinical Analytics focusing primarily on R&D registrational objectives. This role oversees the data sciences, biostatistics, clinical programming and clinical data management capabilities and will lead these essential capabilities in an integrated manner that optimizes the delivery of the clinical data strategy. Reporting to the Chief Data & Analytics Officer (CDAO), and a member of the D&A Leadership Team, this leader will become a driving force of change and delivery across the Data & Analytics organization. - Provide leadership, oversight and technical/scientific direction to the Clinical Analytics organization. A high functioning Clinical Analytics organization would be expected to deliver on both, strong scientific engagement and operational excellence. Specific areas of focus would be inclusive but not limited to the following: efficient and effective trial design and planning, stratification and enrichment considerations, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and presenting.
- In support of the Clinical Development strategy, this role will provide scientific review of materials, inclusive of but not limited to protocols, analysis plans, health authority submission documents, publication materials, etc.. In addition, external scientific interactions will be a core accountability, including but not limited to health authority interactions.
- Operational excellence would be demonstrated through the effective and efficient delivery of the Clinical Development portfolio. This includes but is not limited to the resourcing, prioritization, timeline management, functional outsourcing, etc...
- Participates in Clinical Development portfolio governance and provides insights and strategic direction based on scientific principles, regulatory guidances/precedence and competitive considerations.
- Contributes to D&A departmental governance reviews of portfolio and prioritization discussions. Regular monitoring and reporting on the operational health of Clinical Analytics, through the use of scorecard and metrics reflecting the functional performance of financials, quality and cycle-time.
- Develop and lead the digital strategy for clinical data that is generated through traditional data capture mechanisms as well as through digital mechanisms (e.g. mHealth).
- Function as a knowledge base and resource to project teams. Serves as a point of escalation and resolution for the Clinical Analytics organization and Clinical Development portfolio.
- Models and coaches scientific engagement best practices that enable thought partnership and engender a collaborative environment with robust debate. Furthering the partnership and impact of Biostatistics at Otsuka.
- Fosters a culture that focuses on the achievement of goals and personal accountability, through the setting of goals and expectations, the monitoring to plan and the redirection as needed and the celebration of achievements.
- Fosters a culture that embraces the strategic use of data into decision making through the demonstration of the value data can provide with essential direction enabling greater business outcomes.
- Builds a learning culture within and external to Clinical Analytics, where individuals are provided growth and development opportunities. Drive broad knowledge sharing activities through the use of external expert lectures and trainings as well as internal sharing activities.
- Accountable for ensuring collaborations and communications with key stakeholders to Clinical Analytics.
- Attract, retain, develop and promote talent to build a team with an optimal balance of experience and diverse perspectives.
- As a member of the D&A Leadership Team, models the balance of innovation and intellectual curiosity with discipline and structure. Is a champion of value-add change and evolution and is able to inspire and motivate others.
Knowledge/ Experience and Skills: - Minimum 15 years of industry related experience within the pharmaceutical industry.
- Minimum 10 years of leadership responsibilities required
- Experience working within the pharmaceutical industry with functional leadership experience of a Biostatistics or Statistical business unit.
- Experience supporting clinical portfolios spanning multiple therapeutic areas and development phases.
- Line management experience with multi-functional organization.
- Management of a budget, inclusive of resourcing and outsourcing and discretionary spend.
- Regulatory in-person interaction, e.g. Scientific Advice, Advisory Committee, etc
- Experience driving large, complex change efforts and to drive results through influence, persuasion and relationships
- Assesses quickly with a track record of getting up to speed and adding immediate value to new situations
- Exceptional ability to co-create and work collectively with various business leaders and other key stakeholders
- Excellent oral and written communication skills, including the ability to organize, conceptually interpret and clearly communicate material developed collaboratively via the input of multiple parties; translate complexity into the actionable
- Effective influencing and negotiation skills
- Up to 15% travel is required based upon business needs.
Educational Qualification: - Doctorate degree is required in Biostatistics or similar discipline.
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