Principal Biostatistician

Company: Cytel Software Corporation
Location: Columbia
Posted on: August 6, 2022

Job Description:

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.

We are hiring a remote Principal/Senior Biostatistician to work directly with a pharma company s internal team leading project efforts and providing statistics knowledge . This position reports to the Associate Director of Biostatistics in FSP Services business unit in Cytel.

Your Impact

The (Principal/) Senior Biostatistician position is part of the Research and Development team to develop and provide scientifically sound analyses that answer questions to support product development. The level of this position will be determined based on the amount of the candidate s industry experience and statistical knowledge.

Essential Requirements

• MS or PhD in Statistics, Mathematics, or related field with 3+ years experience
• Excellent writing, communication, and project management skills.
• Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards.
• Support clinical development biostatistics with core deliverables (SAP, CSR TLFs, etc.) and exploratory analyses necessary for submissions and regulatory queries.
• Experience in Neuroscience, Oncology, Early Phase, or Medical Affairs.
• Experience with sample size estimation (e.g., in SAS, R, N-Query, or simulation).
• Specification reviews, Reviewer s Guide contribution/review.
• An additional qualification of Principal Biostatistician: the Principal Biostatistician will bring additional experience (5+ years) and is expected to mentor/manage less experienced staff.
  Skills and Knowledge Requirements
  • Experience in a matrix team environment
  • Excellent written and oral communication skills and demonstrated problem-solving abilities
  • Ability to work proactively while handling multiple deliverables and short timelines
  • Computer proficiency in SAS, Microsoft Word, Excel, and PowerPoint
  • Must be able to prioritize and multi-task, work effectively with little or no direction, and build collaborative relationships with management, partners, and peers from diverse backgrounds.
  • Ability to work across multiple projects
  • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
  • Understanding of study phases and general knowledge of how they apply to biostatics and statistical programming
  • Demonstrated ability to work independently and in a team environment
  • Ability to create and maintain of study-specific data management documents
  • Ability to interface cross-functionally with Data Programming
  • Ability to assist with the training of new study team members
    
    

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