The Global Group Head Biometrics and Statistical Science is an influential leader with a strong understanding of the drug development process, therapeutic knowledge and experience, substantial experience in scientific and Regulatory activities, with well-established track record for strong scientific and organizational leadership, in order to: 1. Lead and oversee ? all aspects of quantitative statistical disciplines ? all development programs within a CSU or Disease area, with a predominant focus on drug development decision making supporting and driving drug development milestone transitions, regulatory approvable dossiers, and there defense globally, market access, commercialization and life-cycle management of products. Provides strategic leadership to the design and development of R&D plans comprising, regulatory, and scientific strategies, impact decisions at management level (CSU, disease area or translational medicine). Provide organizational leadership by managing and developing CSU or Disease area focused global group of 10-40 (Direct and indirect) associates comprised of biometricians and statistical scientist up to and including associates at the Executive director level
1. Provide CSU or disease area level scientific input and strategic influence into drug development design and quantitative decision making, in collaboration with medi-cal/translation medicine leadership.
2. Accountable for strategic statistical input into the CSU or disease are through leadership of a team of Biometricians and Statistical Scientists. Establish relationships with clinical and regulatory drug development partners to enable successful impact on clinical development strategies and drive Quantitative drug development decision making.
3. Member of the Franchise global statistics leadership team. Ensure development of franchise organization as an industry leading biometrics and statistical science or-ganization, engaged internally and externally to influence pharmaceutical statistics practice. Drive high quality objective Health Authority interactions and external relations.
4. Drive technical statistical excellence, through high quality contributions to drug de-velopment in the CSU/disease area, including implementation of innovative methods. Ensure high-quality statistical input, engagement and execution of milestone transitions and regulatory submissions.
5. Through partnership with Scientific Operations Group leadership and IIS FHO, ensure efficient resource management of Biometricians and Statistical Scientists within and across Franchises and effective utilization of partnerships with external vendors.
6. Drive strategies to ensure adherence to Clinical Data Standards through collaboration with the IIS Standards Group, and ensure that data quality is maximized by appropriate study design and in depth knowledge and input on study endpoints.
7. Provide effective input to Data Management activities and partnership with Statistical programming leadership and team to ensure the provision of high-quality data and outputs.
8. Ensure seamless transition of early development projects to full development, and drive collaboration between early and full development statisticians.
9. Effective partnership with Statistical Methodology Group, M&S, and DS&E to ensure integrated quantitative input into development programs.
10. Partner with biometrics and statistical scientist group leadership in India, China and Japan to ensure effective utilization of global resources and ensure colleagues globally are effectively developed.
11. Establish high performing, industry recognized, Biostatistics organization:
? Retain and recruit talent, coach and develop reports
? Mentor biometricians and Statistical scientist team. Responsible for professional development/training and mentoring to enable the highest level of strategic partnership
? Establish and steer a business founded on innovation, collaboration, high per-formance and trust and maintain targeted recruitment strategy for key strategic positions
Education (desirable): PhD in Biostatistics (or equivalent)
Languages: Excellent English required (oral & written).
Requirement: 1. 10+ years industry experience
2. 5+ years multi / cross functional international leadership experience
3. Advanced understanding of the drug development process and programs with significant experience in scientific Regulatory activities.
4. Established track record for strong scientific and organizational leadership.
5. In-depth Therapeutic knowledge and experience in at least one area and proven ability to gain knowledge in new Therapeutic area.
6. Provide thought-leading insights to the competitive environment and internal partner interfaces
7. Proven people leadership capabilities
8. Model natural leadership characteristics in harnessing and managing a diverse business
9. Expert skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
10. Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration
11. Outstanding verbal and written communications
12. Proven track record in working across a matrix organization and demonstrates expert skills in building partnerships, negotiating agreements; excels at collaboration
13. Expert skills in leveraging and maximizing the contribution of diverse team members as both single contributors and as cohesive, efficient teams
14. Drug development expert in R&D encompassing; strategy, science, planning, execution, reporting, regulatory review, submission and commercialization
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