Senior Director of Biostatistics
Location: Fully Remote or Austin, Texas
Highly innovative Biotech looking for their next Senior Director of Biostatistics! We are searching for a dynamic leader to head up a prolific Biostats group. The successful candidate will have excellent leadership, communications, and hands on technical skills under their belt. Please inquire for more details!
Responsible for biostatistical aspects of study design, analysis of study data, and formal communication of study results in order to meet the needs of patients, regulators, and company stakeholders. Defines and implements data analytic and communication strategy and serves as a central point of contact and oversight for Contract Research Organizations who provide statistical services. Position is hands-on, requiring the knowledge and expertise to define optimal approaches to statistical design and analysis. Acts as a thought partner to understand design challenges and offer innovative solutions. Responsible to implement and oversee the statistical aspects of advanced clinical trials and create and execute data presentation plans for regulatory submission.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
Understand the statistical, operational and regulatory challenges and opportunities related to relevant therapy areas and projects in order to bring forward options for statistical approaches in design and analysisead the statistical aspects of, cross-functional project teams, ensuring biostatistically sound and regulatory compliant planning, design, conduct, analysis, and reporting of clinical trials
Manage trial-level budgets for statistical vendors
Effectively oversee and manage the work of vendors providing statistical services.
Provide statistical insight into study design, serving as the subject matter expert in statistics
Participate with clinical development team in investigator meetings, advisory boards, and other clinical/scientific interactions as required
Alert project, line, and senior management as appropriate of possible timeline delays and propose and implement mitigation strategies as appropriate
Develop and leverage constructive relationships with cross-functional project team and work group members to support effective team interactions and delivery of team goals. Collaborate with clinicians, clinical scientists, and pharmacokineticists to interpret and accurately/ appropriately report study results and statistical interpretations.
Have a deep understanding and knowledge International Conference on Harmonization (ICH) and other relevant regulatory guidelines and ensure that statistical deliverables conform to these. Provide expertise and guidance to project teams on such guidelines where relevant.
Ensure that appropriate documented quality control (QC) checks are performed on statistical deliverables, respond to findings, and recommend and implement quality process improvements
Apply technical, line and business knowledge to plan and co-ordinate all aspects of timelines for the statistical deliverables across one or more programs to align with company goals and enable the function to meet its goals. Work closely with program and study teams to reach consensus on clear timelines for deliverables
Liaise with other internal functional areas, including Data Management, Regulatory, Clinical Operations, Project Management, Drug Safety, and Clinical Development to ensure effective execution of studies
Actively participate in the preparation of regulatory submissions and regulatory meetings such as Advisory Committee meetings
Represent the company at academic, medical, industry and regulatory meetings, providing statistical expertise and knowledge to support interactions
Lead cross-functional teams to define/develop/implement new processes/ systems; leverage networks across organization to influence to support change
Job location: London Job salary: £30000 to £40000
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