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Job Description
OBJECTIVE:
Drive statistical biomarker development support for Takeda R&D assets across TAs, to support design and analysis from pre-clinical to early clinical studies.
Drive collaborations with preclinical, biomarker, translational and clinical scientists across TAs and Discovery, including Computational Biology, Imaging, Translational Sciences, DMPK, to contribute to the implementation of preclinical, translational and early clinical strategies and enable early data driven decision making.
Serve as an expert, mentor, and manager in Quantitative Sciences group within Statistical and Quantitative Sciences line implementing biomarker development strategies using cross-disciplinary integrative data analytics.
ACCOUNTABILITIES:
Lead implementation of SQS strategies, goals, and priorities. Oversee and ensure achievement of all deliverables and milestones for multiple programs.
Lead statistical innovation and research strategies in areas including translational medicine, advanced biomarker trial designs, big data analytics (including machine learning and data mining).
Lead digital analytics to support Phase 0 platform technology developments, obtain early evidence of potential efficacy of novel compounds in robust and cost-effective manner to de-risk later phase clinical trials.
Align analytical efforts and resource allocation with TA strategies, portfolio priorities, and partner lines work.
Enable comprehensive biomarker support in top priority areas, such as Cell Therapy, Gene Therapy, Oncology and Orexin franchises.
Strategize and prioritize opportunities for Quantitative Sciences group in AI/ML, RWE, advanced analytics and modeling to maximize impact on the organization.
Manage, mentor and grow interdisciplinary team of computational scientists and contractors to integrate preclinical, translational and early clinical assets to advance R&D programs.
Develop and manage relationships with the external research community. Serve as the scientific point person at the meetings with KOLs, conferences, industry events
Provide statistical leadership in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAs as appropriate.
Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across TAs, including timelines.
Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson.
Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, and sharing of best practices.
Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management
Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAs as appropriate.
EDUCATION, EXPERIENCE AND SKILLS:
PhD in Statistics, Biostatistics, Applied Mathematics, Physics, Engineering, or related quantitative filed with 12+ years of experience
Knowledge of the pharmaceutical drug discovery and development process with a relevant track record of R&D hands-on work and leadership. Experience in both pre-clinical and clinical stages of drug development.
Expertise and track record of implementation of advanced statistical modeling across several TAs.
Expertise in Biomarker and Outcomes instrument validation for clinical trial endpoint use
Pragmatic leader with a focus on driving the teams using fit-for-purpose philosophy and a track record of creativity and innovation.
Track record of integrating discovery/medical and statistical best practices into preclinical and clinical research to improve reproducibility, efficacy, safety of the exploratory endpoints across phases of drug development.
Demonstrated ability to work collaboratively with research project teams in both preclinical and clinical development programs.
Excellent communication and presentation skills. Ability to translate/explain complex statistical concepts to non-experts; ability to speak across disciplines of Quantitative Sciences umbrella: statistics, engineering, applied mathematics, computational biology, pharmacokinetic/pharmacodynamic modeling, and others.
Expertise in statistical programming, modeling and simulations
LEADERSHIP:
Demonstrated ability to work across functions, regions and cultures
Functional level leadership with the ability to inspire, motivate and drive results
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender credibility and confidence within and outside the company
Ability to distill complex issues and ideas down to simple comprehensible terms
Demonstrates leadership presence and confidence
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
Invests time in helping others to enhance their skills and perform at a higher level.
DECISION MAKING AND AUTONOMY:
Decision making responsibilities:
Provide input to highly complex decisions that impact the functional area
Accountable for decision making for designated function
Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
Accountable for providing input to and implementing vision and strategy for designated scope.
INTERACTION:
Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.
Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions.
INNOVATION:
Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation.
Comfortable challenging the status quo and bringing forward innovative solutions
Ability to take risks implementing innovative solutions, accelerating time to market.
Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Role models respect and inclusion, creating a culture that fosters innovation.
COMPLEXITY:
Ability to work in a global ecosystem (internal and external) with a high degree of complexity.
Deep expertise in several areas of statistics is required.
Ability to see and understand broader, enterprise level perspective
