Senior Director, Biostatistics (Real-World Evidence)
Parexel International Corporation
USA - Any Region - Home Based
Parexel’s Business Strategy is how we will execute to ultimately deliver for our customers and patients. Everyone at Parexel, from our Board of Directors to all of our colleagues will play an essential role in delivering our strategy. Our three pillars; “Easy To Do Business With,” “Leveraging Our Strengths,” and “Patient Focus,” are the foundations by which we drive the strategy.
The Biostatistics Senior Director is an experienced KOL in the area of Real-World Data / Real-World Evidence, and is responsible for liaising with senior levels of management within the organization, regulatory agencies and Pharmaceutical and Biotech clients.
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. The Biostatistics Senior Director serves as an executive sponsor for enterprise and biotech accounts promoting client engagement (need to reword this better).
He/she 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. The Biostatistics Senior Director is responsible to actively promote new business by participating in project bids and client presentations as appropriate. The Biostatistics Senior Director works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business.
QualificationsSkills 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 Deep understand and experience with Real-World Data / Real-World Evidence 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 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 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.