Principal Biostatistician

Job Description

• Develop and apply biostatistical theory and methods to the study of life sciences, work closely with other cross-functional key stakeholders, and represent the statistics function in Study Management Teams (SMTs) to provide statistical expertise and operational insight for the management of clinical studies, throughout the study protocol design and development, actual trial execution, database lock, analysis readout and result reporting.
• Investigate and evaluate relevant study design options and conduct statistical simulations to understand the performance and operating characteristics of various design options, and make recommendations to the team on the statistical design options for new protocols under development.
• Review study setup activities including but not limited to study sample size calculation, randomization, CRFs, database setup configurations, interactive voice response system (IVRS), vendor data transfer procedure document and may serve as primary biostatistician at study level.
• Develop statistical analysis plans (SAP) including data and report specifications, perform statistical analyses, interpret statistical results, co-author clinical study reports (CSR), and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
• Contribute to internal decision making, publications of the clinical data, and integrated summaries for regulatory submissions.
• Keep up to date on current methodology research and conduct methodology research driven by study need.
• Analyze and communicate study level resource and quality issues that may impact deliverables or timelines, propose and implement solutions, and escalate issues to management as appropriate.
• Support the development and implementation of company standards. Participate in process improvement initiatives.

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May telecommute up to 100%.

Qualifications

Minimum Requirements:

Position requires a PhD degree (or foreign equivalent) in statistics/Biostatistics or a related field. Position requires demonstrable experience in the following, which can be gained in a professional or academic setting:

• Understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
• Ability to provide solutions to a variety of technical problems of moderate scope and complexity.
• Demonstrable knowledge of medical/biological terminology and clinical trial designs.
• Proficient in statistical programming languages and software, including SAS, R, and computing tools for modelling and simulations.
• Providing statistical solutions (involving data visualization, longitudinal data analysis and modeling, and survival analysis) to a variety of technical problems of moderate scope and complexity.
• Demonstrate effective oral and written communications, good collaborative skills and ability to work with a cross functional team. 

Additional Information

All your information will be kept confidential according to EEO guidelines.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.