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Advance humankind and the organization by analyzing data to determine the causes of issues affecting living organisms including analyzing genetic data and disease occurrence
Role
The role of Biostatistician is to be involved in the design, execution, analysis, and reporting clinical studies across the company
Authority
Assign to project to lead
Planning
Budget and department management
Responsibility
Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining clinical study strategies and delivering results with high quality and on time.
Lead in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs.
Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types.
Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses.
Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence.
Frequently interact with regulatory agencies and effectively address the statistical questions and requests.
Review and/or author SOPs and/or Work Instructions related to biostatistics practices.
Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals.
Oversee statistical contractors/consultants and manage/mentor junior team members.
Requirements
Ph.D. or equivalent degree
9+ years of work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.
Strong statistical knowledge with the ability to apply the knowledge to solve scientific and clinical problems
Working knowledge of relevant FDA, EU, ICH guidelines, and regulations.
Solid experience working with CROs, vendors, and relationship management preferred.
Excellent communication skills
Ability to manage multiple projects in a fast-paced environment
Benefits
It's always a good idea to include the benefits of the job the company will provide such as:
Flexible hours to give you freedom and increase productivity
