Associate Director Biostatistics

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.

With global visibility, 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 clinical trials.

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

Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports.

Assist the Director in proposal development, project allocations, budget projections, and client presentation.

Key Responsibilities:

• Completes and reviews more complex assigned tasks with a focus on accuracy
• 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 in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication
• 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 and/or NDA sections, as required
• Leading studies at an operational level until SAP writing begins

• Management:

• Drive operational pieces of the business segment (e.g. resource management for a business segment, recruitment management for a business segment)
• Provide expert review of process and initiate methodology development work with regards to statistical standards and validation procedures
• Consults on operational/statistical/therapeutic area topics

• Knowledge Sharing:

• Performs as a recognized subject matter expert (SME) who defines training needs and maps out strategies for Director and Senior Directors to approve

• Risk Management:

• Identifies risks to project delivery and/or quality, leads in a way that risks are avoided
• Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions
• Handles most study level escalations that that might impact the account relationship
• Escalates for support to business segment owners/client owners/managers

• Lock and Unblinding Process:

• Leads the database lock and unblinding process
• Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules)

• Statistical Expertise:

• Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for complex and/or integrated reports)
• Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data)
• Provide expert review of ADaM reviewers guide (ADRG)
• Perform senior biostatistician review (SBR)
• Produce or perform quality control review of sample size calculations for complex studies

• Financials:

• Share accountability (with resource managers) for the financial success of studies
• Accountable for controlling costs and maximizing revenue recognition
• Also responsible for sharing budget expectations with team
• 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

• Proposals:

• Participate in sales meetings
• Able to review and write proposals/budgets at a study/submission level ability to understand 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 pric