Biostatistics Senior Director / VP (SME)

The Biostatistics SME 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.

The Biostatistics SME 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. Serves as an executive sponsor for enterprise and biotech accounts promoting client engagement (need to reword this better). The Biostatistics SME 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. Will be responsible to actively promote new business by participating in project bids and client presentations as appropriate. Works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business. Qualifications

Knowledge 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 discipline

EEO 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.