Senior Director, Biostatistics - APAC region

Parexel is seeking a Senior Director, Biostatistics to be based in the Asia Pacific region. We will consider all areas of the APAC region, and assist with relocation.

The Biostatistics Senior Director 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. In this role, you will serve as an executive sponsor for both enterprise and growth accounts, promoting client engagement. You will lead and contribute to strategic initiatives and working groups within Global Data Operations and Biostatistics and Statistical Programming to build a world-class group of Biostatistics experts. You will also be responsible to actively promote new business by participating in project bids and client presentations as appropriate.

Responsibilities

• 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.

Skills

• 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

Education

• PhD in Statistics or related discipline, MS in Statistics or related discipline

*Travel required
*Title level will be discussed and decided according to candidate's experience