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Our client is a global pharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
This Director, Biostatistician position leads a team which supports Medical Affairs studies and exploratory analyses for psoriasis and multiple sclerosis. Knowledge of these areas is preferred but not essential to performance of this position. Excellent people management and communication skills required.
Key responsibilities include but are not limited to:
Leads, initiates, and oversees the statistical support for the development of multiple compounds within a therapeutic area in close collaboration with Clinical Development, Regulatory Affairs, Global Drug Safety, Clinical Pharmacology, and Translational Development partners. Provides guidance and management to statisticians to ensure high quality and timely deliverables. Manages resources within a therapeutic area, sets priorities, and ensures consistency and adherence to standards therein. Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses. Contributes to creation/maintenance of, and provides training on statistical topics and departmental SOPs, WPs. Seeks and responds to stakeholder feedback to increase efficiencies, synergies, and performance. Represents the client at professional societies, and in industry-wide technical discussions. Is sought after as a trusted employee advocate and management coach by senior management regionally. Resolves technical, quality, and timeline issues. Identifies external statistical experts for consultation. Develops performance metrics for staff. Provides guidance to employees’ development plans and carries out performance review and feedback. Manages a functional or project budget, and has authority to allocate company resources according to project needs. Proactively builds partnerships with specialist functions and global counterparts to maximize knowledge and available resources. Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities. Ensures that flexible and rapid responses are provided for statistical requests. Anticipates potential issues and take preventive measures. Identifies and assists in the resolution of bottlenecks for study/project teams. Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests. Represents the company in interfaces with regulatory agencies globally. Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally. Interacts and manages KOLs/CROs and represents the company in external scientific forums. Develops and implements highly innovative solutions to solve complex corporate-wide problems. Provides active coaching to biostatistical team members when developing solutions to problems. Manages team conflicts with external partners/customers. Represents Biostatistics function at high level global project meetings. Act as a resource/mentor to study team members - both internally and externally. Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact. Shapes Biostatistics function, creates and leverages programs, policies, and procedures to provide value added solutions for Biostatistics. Provides input into the long-term Biostatistics strategy and structure. Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports. Member of BDO Management Staff. Provides Leadership. Promotes best practice sharing amongst the broad Statistical and Programming community and focuses on the development of Statisticians/Programmers talent. Effectively manages people and encourages them to seek development opportunities. Drives functional excellence, collaborates with internal and external partners leading by example and thinking strategically. Continually refines and clarifies existing partnerships and relationships by initiating and engaging in projects outside their therapeutic area. Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent.
Ph.D. or MS in statistics or related field. Experience in clinical drug development: 10+ years for Ph.D., 12+ years for MS. Demonstrated skill in the planning, analysis and reporting of clinical trials. Detailed knowledge of statistical methodologies and statistical regulatory requirements. Previous direct supervisory experience of statisticians. Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills. In-depth knowledge of all phases of the global drug development process. Demonstrated ability to work in a team environment with clinical team members. Good interpersonal, communication, writing and organizational skills. Demonstrated skill in resource management. Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards. Abreast of clinical trial development and regulatory requirements for a therapeutic area. Demonstrated development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area. Demonstrated development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas. Ph.D. in Statistics with 10+ (or 12+ years for MS) years pharmaceutical experience in a pharmaceutical R&D environment. Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional.
Please contact Darren Gutowski at firstname.lastname@example.org
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