Principal Biostatistician, Real World Evidence and Personalized Health Analytics
Posted on: 12 Feb 2021
Cambridge, MA
Job Description
Job Description
We have an exciting new opportunity for a Principal Biostatistician of Real World Evidence (RWE) and Personalized Health Analytics (PHA) to join our team in Cambridge, MA. Youll be part of the Medical Data Science and Analytics (MDSA) team in Personalized Health Research, Analytics and Solutions (PHRAS). In this role, youll be responsible for providing biostatistical support and guidance on RWE/PHA studies and may serve as the responsible biostatistician on several projects in different indications.
Primary Responsibilities
* Support cross-function teams in PHRAS to develop real world evidence generation activities based on RWD sources.
* Design, analyze and report RWE/PHA studies in the post-approval setting.
* Implement innovative biostatistical methods with an emphasis on prospective observational study designs and explain their strengths and limitations
* Collaborate with external entities (e.g. thought leaders, academic entities and vendors) in the conduct of RWE/PHA studies
* Support of regulatory submissions, health technology assessments (HTAs) and publications within global, cross-functional teams.
* Increase knowledge of RWE/PHA 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/PHA
LI-TG1
Qualifications
* MS or PhD in Biostatistics, Epidemiology, Outcomes Research, Economics or equivalent, and an MS with 4-6 years or PhD with 4 years working on observational studies.
* Thorough understanding of biostatistics, pharmacoepidemiology, and outcomes research methods in observational studies.
* Expertise in observational study designs used in pharmacoepidemiology
* Experience with secondary data sources including registries, claims and EMR.
* Good understanding of the communalities and differences between primary and secondary data collection.
* Knowledge of drug development (clinical and post-approval) and understanding drug development as a continuum.
* Programming experience with R, SAS or other statistical software packages
* Experience with ICH GCP, regulatory (e.g. EMA and FDA) and HTA (e.g. NICE and HAS) guidelines.
* Ability to work independently on routine assignments and under little supervision on new assignments.
* Demonstrate strong organizational skills, including the ability to prioritize workload.
* Excellent written and verbal communication skills.
Additional Information
Biogen is looking to hire an experienced Principal Biostatistician to provide valuable support on Real World Evidence (RWE) and Personalized Health Analytics (PHA). The successful candidate can be based out of Biogen's US Headquarters in Cambridge, MA or can be remote.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
