The Biostatistics Senior Director/ Vice President is responsible for statistical consulting, strategic advice and operational execution in drug/device /diagnostic developments up to submissions and approvals as well as successful reimbursement applications. He or she serves as an executive sponsor for enterprise and growth accounts promoting client engagement (need to reword this better).
This individual leads and contributes to strategic initiatives and working groups within GDO and Biostatistics and Statistical Programming to build a world-class group of Biostatistics experts. He/she is responsible to actively promote new business by participating in project bids and client presentations as appropriate. The individual works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business.
This is an experienced leader responsible for liaising with senior levels of management within the organization and to deputize for the Vice President or Corporate Vice President as needed.
Excellent organizational, communication, negotiation, problem-solving, analytical and consulting skills
Technical leadership and contribute to a high performing team
Expertise in optimizing trial design, development programs, submission strategies and regulatory interactions
Outstanding understanding of the drug, device or diagnostic development process
Expertise in broad different therapeutic areas and indications
Thorough understanding of various statistical models and applications
Excellent understanding of statistical issues in clinical trials and strategies to avoid them
Thorough understanding of regulatory guidance and practices pertaining to specific indications and also to submissions and approval processes
Thorough understanding of e-submissions, eCTD, etc
Thorough understanding of ICH guidelines
Excellent knowledge of all statistical and reporting processes within the Biostatistics department.
Strategic awareness of our business environment
Knowledge of the International pharmaceutical market and the services required by sales, marketing and operational support to achieve product success
An ability to assess situations and make and carry through difficult decisions
Advanced ability to successfully manage a full workload across multiple-projects
Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer
Advanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Advanced ability to work in a matrix environment and to value the importance of teamwork
Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook
Knowledge and Experience
Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge
Direct experience in consulting
Proven record and experience with development, execution and implementation of research strategies in the pharmaceutical industry
Experience in designing and executing drug, device or diagnostic development programs
Demonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agencies
Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation
Experience with conference presentation and manuscript writing
Telecommuting is allowed.
Internal Number: 51261BR
About PAREXEL International
PAREXEL International Corporation is the world’s leading innovator of biopharmaceutical services. We simplify our clients’ journey of transforming scientific discoveries into new medical treatments for patients with high-quality Phase I-IV clinical research, regulatory, consulting and market access services. PAREXEL develops breakthrough innovations and solutions by leveraging its comprehensive therapeutic, technical and functional expertise, in more than 100 countries around the world.
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