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Senior Director / Vice President, Biostatistics

United Kingdom - Any Region - Home Based Date posted 04/03/2019 Job ID 51710BR

As a Biostatistician at PAREXEL you’ll work on a variety of projects, while collaborating with our global team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas, become involved in business development activities, and have the opportunity to grow and develop your career within a flexible working environment. You’ll also contribute to research design and analytical strategies, provide input into protocols, and develop and review statistical analysis plans.

  • Full Time
  • Level: Mid
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Analytical
  • Communicator
  • Leadership
  • Efficient
  • Tech-Savvy
  • Personable
  • "PAREXEL is very team oriented, so you work with a lot of people and also get to work in different therapeutic areas. There are many opportunities to find what you enjoy and the management is very supportive."

    James - Principal Biostatistician
  • "From a new graduate to a well-trained Biostatistician, I have definitely gained significant experiences in PAREXEL over the past three years. At PAREXEL I have always felt valued and supported, my strength got recognized and optimized here and my work got appreciated. I am very proud to be a part of the organization."

    Fiona - Biostatistician II

Rewards

  • Career Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Balance

    We value work-life balance. We try and keep regular hours and a flexible working enviroment.

  • Open communication

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Systems

    Utilize PAREXEL’s industry leading clinical systems and solutions

  • Mentoring program

    Strong mentors with depths of experience working for global health authorities.

Responsibilities

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

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