Associate Director of Digital Transformation

OverviewJob Overview :We are looking for an Associate Director, Biostatistics to manage a team of Biostatistics staff. In addition, to :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 observational database studies. Assist the Director in strategic planning and resource allocation for the department. Assist the Director in proposal development, project allocation, budget projections, and client presentation, as needed.
Responsibilities Production of High-Quality Deliverables : Ensure the high quality and timeliness of deliverables from the department and ensure the high quality of the expert review process
Maintain knowledge and awareness of developments in Biostatistics and RWE studies 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. May participate as high level lead biostatistician on major project(s) including developing / reviewing protocols, preparing analysis plans, and writing sections of joint clinical / statistical reports, integrated summaries or eSubmissions, as required. 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. Approve actions on human resource matters. Accountable for the project level work of staff including awareness of timelines, scope and resourcing strategy. 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. Partners with management to define strategy and initiatives for particular client / service group. Develop and / or provide training to staff across the business unit. Risk Management : Identifies risks to project delivery and / or quality. Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions. Handles study level escalations and assist in high level escalations that might impact the account relationship. Proposals : Participate in sales meetings as required (if a client head : attends defenses that could potentially expand the account). Able to review and are being trained to 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
Typically requires 7-10 years of prior relevant experience, including 2 years experience managing staff or Equivalent combination of education, training and experience.
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments.
Familiarity with most complex statistical methods that apply to observational database studies.
In-depth knowledge of applicable clinical research regulatory requirements, i.e., Strong working knowledge of R or SAS.
Excellent written and oral communication skills with good interpersonal skills.