Biostatistician

Department Mission
  • 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
  • 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
  • etc.

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