Biostatistics Senior Director / VP

*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.

QualificationsQualifications

SkillsExcellent organizational, communication, negotiation, problem-solving, analytical and consulting skillsTechnical leadership and contribute to a high performing teamExpertise in optimizing trial design, development programs, submission strategies and regulatory interactionsOutstanding understanding of the drug, device or diagnostic development processExpertise in broad different therapeutic areas and indicationsThorough understanding of various statistical models and applicationsExcellent understanding of statistical issues in clinical trials and strategies to avoid themThorough understanding of regulatory guidance and practices pertaining to specific indications and also to submissions and approval processesThorough understanding of e-submissions, eCTD, etcThorough understanding of ICH guidelinesExcellent knowledge of all statistical and reporting processes within the Biostatistics department.Strategic awareness of our business environmentKnowledge of the International pharmaceutical market and the services required by sales, marketing and operational support to achieve product successAn ability to assess situations and make and carry through difficult decisionsAdvanced ability to successfully manage a full workload across multiple-projectsExcellent 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 customerAdvanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailAdvanced ability to work in a matrix environment and to value the importance of teamworkComprehensive knowledge of relevant software: Windows, Word, Excel, OutlookKnowledge and ExperienceSignificant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledgeDirect experience in consultingProven record and experience with development, execution and implementation of research strategies in the pharmaceutical industryExperience in designing and executing drug, device or diagnostic development programsDemonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agenciesExperience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participationExperience with conference presentation and manuscript writingEducationPhD in Statistics or related discipline, MS in Statistics or related disciplineEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.