Also considering Applicants from Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden and Switzerland.

Purpose of the job:

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. The Biostatistics Senior Director serves as an executive sponsor for enterprise and growth accounts promoting client engagement (need to reword this better). The Biostatistics Senior Director / Vice President 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. S/he is responsible to actively promote new business by participating in project bids and client presentations as appropriate. S/he works closely with Business Development and Solutions Consultants to promote Biostatistics engagement to drive new business. The Biostatistics Senior Director 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.

Key Accountabilities:

Offer world-class Biostatistics consulting and operational execution

Provide consulting and guidance throughout the clinical development process

Provide statistical expertise in designing clinical development programs, individual protocols, optimizing existing protocols, preparing submissions

Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client

Support interventional and non-interventional studies

Review and participate in writing publications

Act as executive oversight of a large project where applicable

Business Development:

As a world-class expert in Biostatistics and Statistical Programming attract new business for PAREXEL

Work closely with Business Development, Medical, Solutions Consultants and other PAREXEL functions and attend client meetings as a subject matter expert in Biostatistics

Contribute to business development, e.g., by actively contributing to proposal development (in particular if complex statistical designs or analyses are part of the proposal), attending and preparing bid defense meetings for potential studies, programs of work and functional service providers.

Represent PAREXEL at client marketing and technical meetings as needed

Participate in and contribute to project bids, including client presentations.

Provide on-going support to Portfolio Management,
Business Development, and Business Operations groups

Support efforts for generating business leads (client networking, public speaking, etc)

Client Engagement and Other Activities:

Serve as Executive Sponsor for Biostatistics and Statistical Programming for Enterprise and Growth Accounts

Attend client governance meetings as appropriate

May be responsible to coordinate client or account activities for department or function

Participate in committees, task force groups as needed

Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and PAREXEL

Work with senior departmental management in developing managers and ensuring a talented pipeline of management staff within the department or function

Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and PAREXEL SOPs

Participate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary

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

Expertize 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