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Biostatistics Senior Director / VP

Chengdu, China | Parexel

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
Job Description:
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*Location: All China region is considered and can be discussed

*Travel required

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


Responsibilities

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.


Qualifications


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


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