Senior Biostatistician

• The Senior Biostatistician provides statistical expertise to support clinical research, regulatory submissions, and product development activities. This role is responsible for the design, analysis, and interpretation of clinical studies and serves as a key statistical resource for interactions with regulatory agencies including the FDA.
• The Senior Biostatistician serves as a statistical consultant to cross-functional teams including Product Development, Process Development, Quality, and Operations. The role supports engineering and scientific teams in the application of sound statistical methodology including design of experiments (DOE), test method validation, and data analysis to support product and process development.
• This position collaborates closely with teams in the United States and Europe to ensure appropriate statistical methods are applied to clinical, engineering, and operational challenges.

• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other duties as assigned

 

Major Areas of Accountability

 

Clinical Research and Regulatory Support

• Provide statistical leadership for the design, analysis, and interpretation of clinical studies.
• Develop statistical analysis plans (SAPs) for clinical investigations.
• Perform statistical analyses of clinical study data and generate tables, listings, and figures.
• Collaborate with clinical scientists, medical affairs, and regulatory teams in preparing clinical study reports and regulatory submissions.
• Support responses to statistical questions from regulatory authorities including the FDA and other global regulators.
• Provide input on study design including sample size calculations, randomization strategies, and endpoint selection.

 

Cross-Functional Statistical Consulting

• Serve as a statistical consultant to product development, process development, quality, and operations teams.
• Support engineering teams in the application of statistical techniques such as:
  • Design of Experiments (DOE)
  • Test method validation
  • Process capability analysis
  • Reliability and life data analysis
  • Measurement system analysis
• Assist teams in developing statistically sound experimental designs and interpreting results.

 

Education and Capability Development

• Provide guidance and education to engineering and scientific teams on the appropriate application of statistical tools and methods.
• Promote best practices in statistical thinking across the organization.
• Support teams in selecting and applying appropriate statistical software and methods.

 

 

Data Analysis and Communication

• Analyze complex datasets and clearly communicate statistical findings to both technical and non-technical audiences.
• Prepare statistical reports and presentations for internal stakeholders and regulatory submissions.

 

Basic Qualifications

• MS in Statistics, Biostatistics, or a related quantitative discipline required
• 3–7 years of relevant experience in medical device, pharmaceutical, biotechnology, or contract research organization (CRO) environments
• Demonstrated experience supporting clinical studies and statistical analysis of clinical data
• Experience interacting with regulatory authorities (FDA or equivalent) preferred
• Experience in applying statistical methods to engineering or product development activities is highly desirable

 

Required Knowledge, Skills and Abilities

• Strong knowledge of biostatistics and clinical trial methodology
• Experience with statistical software such as SAS, R, JMP, Minitab or equivalent
• Knowledge of design of experiments (DOE) and other statistical tools used in engineering environments
• Familiarity with medical device de