Director / Sr. Director, Biostatistics & Data Management
Director/Sr. Director, Biostatistics and Data Management
Our client is a publicly-traded biomedical firm seeking a Biostatistician who will report to the Chief Scientific Officer (CSO). While the client prefers local candidates, they are willing to assist in relocating the right candidate. The individual will be responsible for:
· Under the guidance of the CSO, collaborate and assist in the design of clinical trials
· Collaborate with the clinical team in all data and database related efforts
· Responsible for authoring the statistical sections of product concepts, study protocols, protocol amendments, clinical development plans, and any integrated planning
· Participate on clinical trials teams as a resource to assist in statistical and data efforts
· Collaborate in preparation and/or assistance in the review of sections of materials for briefing packages to agencies, and responses to health, regulatory bodies and ethics committees
· Provide expert and independent statistical expertise (including through the use of external experts when needed) in support of a compounds and products. This includes guidance on statistical methods, appropriate study design and interpretation of results; strategic input into clinical development planning; and management of analysis and reporting deliverables.
· Collaborate with the CSO with respect to development of specific analysis methodologies and evaluation/implementation of specific regulatory guidance.
· Collaborate with the project teams, specifically clinical for specific data and reporting standards by guiding external partner organizations, including CROs
· Collaborate with the CSO to define and lead the analysis of relevant internal and external information to inform design decisions. Responsible for statistical aspects of internal discussion. Authoring or overseeing authorship of statistical analysis plans (SAPs). Authoring or overseeing authorship of statistical programming plans.
· Collaborate with the CSO and CMO in the statistical thinking for all aspects of the development process including definition of the target product profile/claim, formulation of go/no-go/futility criteria, evaluation of benefit/risk profile, and development of associated regulatory strategy.
· Collaborate and effectively work with clinical colleagues by driving statistical thinking, proper obtaining of data, appropriate data interpretation and disciplined exploratory data analysis
· Collaborate with the CSO, and influence the broader organization with respect to innovation in clinical study design
· Responsible for statistical content and data interpretation for Clinical Study Reports (CSRs) and publications or presentations. Manage developmental efforts including deliverables provided by internal resources and outsourcing partners/providers. Effectively negotiate timelines or competing company priorities among a variety of stakeholders. Provide statistical guidance/oversight to internal clinical team and other stakeholders. Collaborate in protocol synopsis planning, study planning, project planning and program planning
· Collaborate in discussions with external statisticians, data analysts, internal and external clinical operations team members and regulatory personnel for the tasks described above
· Collaborate with the CSO and CMO in the planning and reviewing of data from all clinical trials.
· Collaborate with the CSO, CMO and Regulatory in the planning and execution of the integrated summary of safety (ISS), the integrated summary of efficacy (ISE), and all other regulatory (preIND, NDA, MAA, end of phase 2, Type C meetings, and the like with European and other regulatory and health bodies) and nonregulatory statistical and data portions
· Collaborate with the CSO, CMO, Regulatory and clinical team in driving and managing of external vendors and writers on statistical and data sections deliverables
· Collaborate in planning and execution of informal and formal slide decks and other documents, where data and statistical analyses are required
· Collaborate with the drug and device groups where needed
· Collaborate with corporate development in design and execution efforts with internal and external stakeholders
· Collaborate with project management for all projects for contract, budget, scope and time
· Ensure that internal standard procedures and working practices are followed
Canidates MUST possess the following:
· MS or PhD in statistics or other related field with high statistical content
· Minimum 10 years of industry experience in a pharmaceutical drug or biologic clinical study environment either directly or working in a contract organization
· Comprehensive knowledge of statistical methods and applications in study design and analysis
· Ability to innovate creatively in a clinical study design setting.
· Ability to communicate with clarity and with an independent voice
· Ability to challenge (in good faith) the broader clinical organization to drive organizational thinking within studies
· Ability to defend statistical methods at the senior cross functional level
· Ability to collaborate to make tough decisions to drive the right business outcome
· Knowledge of ICH/EMA/FDA guidelines.
· Demonstrated ability to serve effectively on teams
· Demonstrated ability to manage, mentor and drive external partner contract organization statistical and data teams
· Ability to drive and manage data tables, data analyses and database builds with external partners and as requiredinternally
· Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.
· Experience in regulatory interactions and submissions
· Experience in contributing and collaborating with both scientific/medical and regulatory documentation within formal developmental efforts
· Willing to work collaboratively with peers and in a team environment
· Willing to relocate to the Atlanta area