Assoc Biostatistics Director (Onc)

Job Overview
With global oversight, 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, as needed.  Conduct independent research and teaches courses in statistical methodology as resources permit.

Essential Functions
• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Oversees team with same expectations.
• Leadership:  Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company. Maintains knowledge and awareness of developments in Biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. Represent clients at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee.  As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication. 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 and/or New Drug Applications (NDA) sections, as required. May be 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 regard to statistical standards and validation procedures. Consults on operational/statistical/therapeutic area topics. May play a direct part in talks with regulatory agencies.
• Customer:  Serves as primary point of contact for customer. Responsible for building and maintaining effective client relationships. Consults on operational topics with clients. Consult on statistical programming topics. May be brought into a client group to guide strategy around standards based on past experiences.
• 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. May also be brought into a client group to guide strategy around standards based on past experiences. Mentors senior staff, including offshore. Creates multiple technical offerings that have impact at a global level and plays a role in training and rollout. Provides new topics and training materials at a department/site/team/global level.
• 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. May participate on the Biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules). Oversees lower level Bios new to unblindings. 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, validation checks and critical data). Provide expert review of ADaM reviewers guide (ADRG). May perform senior biostatistician review (SBR). Produce or perform quality control review of sample size calculations for complex studies.
• Financials:  Shares 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 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 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 pricing models.
• Other Responsibilities:  As defined on ad-hoc basis by senior management. May assist with cross functional collaboration. Perform senior biostatistical review (SBR), where applicable.

Qualifications
• Bachelor's Degree Biostatistics or related field and 7 - 10 years relevant experience Req Or
• Master's Degree Biostatistics or related field and 7-10 years relevant experience Req Or
• Ph.D. Biostatistics or related field and 5 years relevant experience including 2 years experience managing staff Req
• Typically requires 7-10 years of prior relevant experience, or equivalent combination of education, training and experience.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. Typically viewed as having a specialty within discipline.
• Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong working knowledge of SAS.
• Excellent written and oral communication skills with good interpersonal skills.
• Excellent problem solving skills.
• Excellent presentation skills.
• Sound judgment/decision making.
• Ability to lead and motivate a team.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).

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