Duties:

• Responsible for leading study design and data analysis, providing statistical expertise for company products within one or more therapeutic areas in clinical development, biomarker development, research, Biotherapeutic and Medicinal Sciences (BTMS) or Pharmaceutical Operations & Technology (PO&T).

• Act as independent Study Management Team (SMT) or Research and Development Project Team (RDPT) Biostatistician.

• Define statistical methodology, analyze data, report results, and contribute to the strategic planning and execution of the clinical development plan for the assigned project/program.

• Provide statistical input in the scientific discussion, participate in protocol development, integrated and study statistical analysis plans and file/report specifications development, prepare clinical study reports including integrated summaries for submissions.

• Train and supervise contract statisticians and ensure the quality and timeline of key deliverables.

• Assist in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners.

• Represent Biostatistics in key meetings including internal and external stakeholders, regulatory interactions.

• Conduct methodology research, modeling, and simulation to timely identify and resolve complex statistical issues per program needs.

• Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry.

• Contribute to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and mentoring new/junior biostatisticians.

• Telecommuting permitted up to 50%.

Minimum Requirements:

Ph.D. Degree or foreign equivalent in Biostatistics/Statistics or related field and 3 years of experience in the job offered or in a Sr. Principal Biostatistician-related occupation.

Alternatively, employer will accept a Master degree (or foreign equivalent) in Biostatistics/Statistics or related field and 6 years of experience in the job offered or in a Sr. Principal Biostatistician-related occupation.

Position requires 3 years of experience in the following:

• Demonstrated thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.

• Demonstrated ability to provide technical solutions to a wide range of difficult problems with solutions that are innovative, thorough, practicable, and consistent with objectives.

• Utilized working knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant multiple sclerosis and immunology therapeutic areas.

• Conversant with statistical programming languages and software, including R/Splus, SAS, RStan, East, FACTS, Spotfire and nQuery; as well as computing tools for modeling, sample size calculations, and clinical trial simulations.

• Demonstrated working knowledge of regulatory guidelines and commercial needs relating to study reports and statistical components of regulatory submissions, including familiar with Clinical Data Interchange Standards Consortium (CDISC) standards, estimands, covariates adjustment, and non-inferiority.

• Demonstrated working knowledge of statistical analysis, including but not limited to multiplicity adjustment, multiple imputation, longitudinal data analysis, Bayesian go/no-go decision making and adaptive design.

• Demonstrated ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.

• Served as statistical lead for late-phase clinical trials and demonstrated working knowledge of managing late-phase clinical trial conduct and execution.

• Demonstrated leadership skills with effective communication including being able to explain methodology and consequences of decisions in lay terms, write and present information effectively to cross-functional team as well as internal and external stakeholders.

• Demonstrated ability to translate requests to meaningful and relevant hypotheses/statistical questions.

• Telecommuting permitted up to 50%.

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

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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.