Vacancy expired!
Job Description
We have multiple Biostatistician openingsand are hiring Senior Biostatistician to Associate Director levels. You’ll be part of thePersonalized Health Research, Analytics and Solutions (PHRAS) teamwithin our Biogen Digital Health organization. In thisrole, you’ll be responsible for providing biostatistical support and guidance on RWE/PHA studies and may serveas the responsible biostatistician on several projects in different indications.
At Biogen Digital Health (BDH), we aspire to transform Biogen and patients’ lives by making personalized & digital medicine in neuroscience a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence, innovation, and collaboration.
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
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Qualifications
- MS or PhD in Biostatistics, Epidemiology, Outcomes Research, Economics or equivalent.
- 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
Why Biogen Digital Health?You will join an international, diverse team of 100+ talented humans who are passionate about making our vision a reality. Our team at Biogen Digital Health rejects the status quo and lives by agile principles. You’ll work directly with an outstanding team of neuroscientists, clinicians, data scientists, biostatisticians, digital product managers, user experience designers, and engineers that work across disciplines to make a lasting impact for patients.
Vacancy expired!