- Advance humankind and the organization by analyzing data to determine the causes of issues affecting living organisms including analyzing genetic data and disease occurrence
- The role of Biostatistician is to be involved in the design, execution, analysis, and reporting clinical studies across the company
- Assign to project to lead
- Budget and department management
- 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.
- 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
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
- Life insurance for you and your family members
- Work remotely in the comfort of your home
- Free Gym membership so you can stay in shape
- Fun and Energetic weekly team bonding events
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