The Biostatistics, Subject Matter Expert 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 serves as an executive sponsor for enterprise and biotech accounts promoting client engagement.
The Biostatistics SME works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business. 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.
- 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.
- Responsible to actively promote new business by participating in project bids and client presentations as appropriate.
- 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 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
Knowledge and Experience
- 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
- 10-12 years of 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
- PhD in Statistics or related discipline, MS in Statistics or related discipline
Parexel 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.
Posting ID: 582190822Posted: 2020-10-24