Associate Director, Biostatistics Real World Evidence
Descripción del trabajo
Associate Director, Biostatistics
Join us on our exciting journey!
The vision of our Real-World Evidence teams is to pioneer and lead with scientific and technical expertise, the generation and dissemination of high-quality Real-World Evidence that make a true difference to patient lives, globally. Come join us on this exciting journey!
Our Real-World Global Biostatistics & Statistical Programming team delivers insightful analytics for predominantly primary data collection studies, and we are increasingly supporting innovative studies such as External Comparators, Enriched Studies, and Pragmatic Trials.
We are a highly motivated global team of more than 150 employees, responsible for engaging with our clients early to help shape the statistical analysis in these various study designs; contribute to protocols and deliver results that meet their needs.
We have unique opportunities to define the way our clients develop and apply Real-World Evidence for healthcare decision making, so we are looking for the best talent to join us in this effort.
We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of Real-World Evidence in an evolving industry!
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.
- Ensure the high quality and timeliness of deliverables from the department and ensure the high quality of the expert review process
- 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
- 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
- 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
- Client/service group owner with moderate or building business unit portfolio presence
- Responsible for client/service group level Strategies and Initiatives
- 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
- BSc or MSc degree in Biostatistics or related field and 10+ years’ 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)
You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately, improve outcomes for patients.
Whatever your career goals, we are here to ensure you get there!
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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