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 development and regulatory requirements
• Ability to translate complex statistical concepts into practical guidance for cross-functional teams
• Strong analytical, problem-solving, and critical thinking skills
• Excellent written and verbal communication skills
• Ability to collaborate effectively with multidisciplinary teams across multiple geographic locations
• Ability to manage multiple projects and priorities in a dynamic environment

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The compensation range for this position is $100,274 - $162,287. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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