Good afternoon AllStat
Our Client is currently looking to hire a talented Associate Director, Statistical Science (Clinical), in a permanent role based in Switzerland.
In this challenging and dynamic role you will be global lead for the statistical strategy of multiple indications (or equivalent) within (pre/early/full) clinical development. They are responsible for the discussion and implementation of modern and innovative trial designs, statistical models, and analysis methodologies that optimize the drug development program for each indication. You will set the strategic direction for addressing statistical issues in regulatory submissions, and directly influence drug development decisions with internal and external partners.
Responsibilities
•Provide strategic statistical scientific global leadership to the clinical development programs, comprising all relevant technical and disease area knowledge
•Drive and steer the strategic quantitative framework for (pre/early/full-) clinical programs in close collaboration with (early) project teams
•Represents the GPT internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent program quantitative risk/probability of success assessments
•In collaboration with clinical counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams, influence and negotiate clinical development plans. Leads the quantitative evaluation of competing program/trial/analysis strategies assuring robust clinical development planning and execution.
•Defines and drives statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Target Product Profile, Briefing Books, Risk Management Plan and responds to HA questions)
•Drives the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners, facilitates and manages internal and external stakeholders through to regulatory acceptance.
•Drives and coordinates the synthesis and integration of information to support transition of drug development milestones / decision boards. Identifies alternative strategic options to risk mitigate programs – thus limiting potential negative impact on (pre/early/full-) program success
•Leads statistical scientific evaluation of in-licensing opportunities
•Represents IIS at project level internal/external meetings with respect to statistical scientific input and in portfolio level governance boards (e.g TM forum, IFB)
•Ensure full integration of Statistical Methodology, make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned.
•Interacts with Health Authorities and external key opinion leaders as the recognized company expert at the program (or equivalent) level for all quantitative aspects of the program. Represents IIS at across global regulatory hearings/advisory committee meetings and other global regulatory interfaces
•Provides biostatistics and drug development expertise to infrastructure and process improvement initiatives; may lead such initiatives
•Provides technical statistical expertise and leadership and serves as a role model for innovation on behalf of IIS
•Serves as mentor, and may undertake role of development/appraisal coordinator for selected IIS Franchise associates
Minimum requirements
•PhD in Statistics (or equivalent degree/knowledge)
•3+ years industry experience
•Experience with designing survival type studies
•Strong disease area and guidelines knowledge.
•Proven track record of developing/establishing statistical excellence. Established experience in leading global scientific improvement/change initiatives
•Strong interpersonal and communication skills ( verbal and writing) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence
•Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies
•Natural modern leadership style building partnerships and collaborative environments
•Expert skills to facilitate and maximize the contribution of quantitative team
•Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign
For further information, please contact [log in to unmask]
Thank you for your interest
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