Associate Director (Biostatistics)

Currently recruiting for an Associate Director of Biostatistics for   my clients RWE team. The position is on a permanent basis working remotely in the UK or Europe.

The successful candidate will join an award winning company, listed in the Forbes 2020 for worlds best employers. They employ the best minds to help push the boundaries of human and data science.

You will be given access to cutting-edge in-house technology, allowing you to work on global projects across a variety of therapeutic areas. You will be able to progress your career in the direction you choose to go and will encourage and mentor you along the way.

Job Overview

As an Associate Director, Biostatistics, you will join one of the largest, award winning and innovative Biostatistics departments and will be given access to cutting-edge in-house technology, allowing you to work on global projects and thanks to our development opportunities and mentoring at all levels, you will be able to progress your long-term career in the direction you choose.

With regional/site presence, manage a team of Biostatistics staff and fulfil the role of site head or functional head within a site.

Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.

Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to Real-World Evidence.

Assist the Director in strategic planning and resource allocation for the department.

Participate as oversight across studies and/or customers including guidance on documentation and output development/review.

Assist the Director in proposal development, project allocation, budget projections, and client presentation, as needed.

Conduct independent research and teaches courses in statistical methodology as resources permit.

Responsibilities:

• Ensure the high quality and timeliness of deliverables from the department and ensure the high quality of the expert review process

Leadership:

• Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company
• Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses
• Represent clients at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee
• Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries or eSubmissions and/or new drug applications (NDA), as required
• Provide advanced technical expertise for internal and external clients
• Assist and contribute to governance structures where relevant

Management:

• Manage staff in accordance with organization’s policies and applicable regulations
• Responsibilities include planning, assigning, and directing work, appraising performance, and guiding professional development, rewarding, and disciplining employees, addressing employee relations issues, and resolving problems, ensure compliance with operational components (e.g. SOPs, Timesheets)
• Approve actions on human resource matters.
• Accountable for the project level work of staff including awareness of timelines, scope, and resourcing strategy.
• Responsible for guiding leads toward financial success at a study level

Financials:

• Accountable for controlling costs and maximizing revenue recognition at a client/service group level
• Regarding ownership of operational components, ensure remit is in line with or maximizes business unit needs to control costs and maximize revenue recognition
• Provide support to leads regarding estimate at completion (EAC) reporting

Strategy and Initiatives:

• Client head/service group owner, partners with management to define strategy and initiatives for client/service group
• Provide feedback to draft strategy and initiatives
• Implements strategy and initiatives and collects feedback from the implementation (e.g. metrics)
• Develop and/or provide training to staff across the business unit
• Ensures compliance with strategy and initiatives
• Owns/manages components of larger strategy and initiatives
• Owns/manages small focused initiatives and/or components of larger focused initiatives
• Collaborate with other business units to execute strategies for process improvement

Customer:

• Client/service group owner with moderate or building business unit portfolio presence
• Responsible for client/service group level Strategies and Initiatives

• Proposals:

• Participate in sales meetings as required (if a client head: attends defenses that could potentially expand the account)
• Able to review and write proposals/budgets at a study/submission level, understanding of what goes into a budget, how to propose adjustments, and be able to discuss budget assumptions with clients as well as the ability to understand and discuss pricing models

Requirements:

• BSc or MSc degree in Biostatistics or related field relevant experience within the life-science industry, along with at least 2 years’ experience in managing staff
• Familiarity with complex statistical methods
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Familiarity with moderately complex statistical methods
• Strong working knowledge of SAS
• Working knowledge of relevant Data Standards (such as CDISC/ADaM)

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.