Biostatistician

Responsibilities

• Provide statistical expertise in the design and analysis of clinical trials.
• Develop and author SAPs for assigned projects.
• Review clinical trial protocols to ensure statistical soundness and provide feedback to study teams.
• Author the protocol statistical sections and generate SAPs and study randomization.
• Analyze clinical trial data using advanced statistical techniques and software.
• Collaborate closely with Statistical Programmers to review and validate data sets, tables, listings, and other statistical outputs.
• Review and sign-off on relevant study documents and data management and programming deliverables.
• Provide programming support to supplemental or exploratory analyses any other internal and external ad-hoc requests.
• Stay current with relevant regulatory guidelines and ensure compliance in all statistical deliverables.
• Represent the biostatistics function on project teams and in cross-functional meetings.
• Perform other duties as required and assigned.
  

Accountabilities

• Demonstrate efficient and accurate completion of all responsibilities.
• Support overall delivery strategy and OKRs as directed by management.
  

Education

• Master’s or PhD in Statistics, Biostatistics, or a related field is required.
• Bachelor’s degree with substantial working experience in biostatistics will be considered.
  

Experience

• 2+ years of biostatistics experience, preferably in clinical trials.
• Proficiency in statistical software such as SAS, R, or Python required.
• Experience in the life sciences, regulatory environments, and knowledge of 21 CFR Part 11 and GxP is highly preferred.
  

Skills

• Strong statistical knowledge, including experience with survival analysis, mixed models, and longitudinal data analysis.
• Excellent problem-solving abilities and attention to detail.
• Demonstrated ability to work independently and within cross-functional teams.
• Strong written and verbal communication skills, with the ability to clearly present statistical findings.
• Familiarity with regulatory requirements for clinical trial data.