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Principal Biostatistician - Real World Evidence (RWE)
Biogen | Cambridge, Massachusetts
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Job Description

External Posting TitlePrincipal Biostatistician - Real World Evidence (RWE)
Job DescriptionOverview
We have an exciting new opportunity for a Principal Biostatistician to join our team in Cambridge, MA. You'll be part of the Real World Evidence (RWE) analytics team within Biometrics. In this role you'll be responsible for providing statistical support and guidance on RWE studies as assigned by your line manager and may serve as the responsible RWE statistician on several RWE projects in different indications.

Primary Responsibilities

•Support of cross-functional teams in developing clinical development plans (CDPs), including post approval commitments and/or requirements for regulatory authorities like EMA and FDA.

•Support of cross-function teams in developing life cycle management plans (LCMPs), including data generation activities based on RWD sources (post approval setting).

•Designing, execution, analysis and reporting of RWE studies in the pharmaceutical industry setting.

•Close collaboration with external entities (e.g. key opinion leaders, academic entities and CROs) in the conduct of RWE studies

•Support of regulatory submissions, health technology assessments (HTAs) and publications within global, cross-functional teams.

•Implementation of appropriate statistical techniques and ability to explain their strengths and limitations

•Increase knowledge of RWE and indirect (network meta-analysis) methods and their implementation

•Increase knowledge of RWD sources (e.g. disease registries and claims)

•Participate in cross-functional initiatives regarding RWE
LocationCambridge, MA, US
Job CategoryBiometrics
Requisition Number31597BR
QualificationsQualifications / Skills

•Knowledge of drug development (clinical and post-approval) and understanding drug development as a continuum.

•Experienced with ICH GCP, regulatory (e.g. EMA and FDA) and HTA (e.g. NICE and HAS) guidelines.

•Thorough understanding of statistical and epidemiologic methods used in RWE studies.

•Good understanding of the communalities and differences between primary and secondary data collection.

•Programming experience with R, SAS or other statistical software packages

•Ability to work independently on routine assignments and under little supervision on new assignments.

•Demonstrate strong organizational skills, including the ability to prioritize workload.

•Demonstrated ability to work as part of a cross-functional team.

•Good strategic ability (including problem solving, critical thinking skills and thinking cross-functional).

•MS or PhD in Biostatistics, Statistics, Epidemiology, Outcomes Research, Mathematics or equivalent, or, MS with 4-6 years or PhD with 4 years working on clinical trials or observational studies.
About BiogenCorporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

Our Science

We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.

For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer's disease, Parkinson's disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry's most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.

Our Corporate Citizenship

The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek's 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science's list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

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.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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