Senior Biostatistician II at Biogen in Cambridge, MA

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Summary
The Senior Biostatistician II is responsible for providing statistical support as assigned. He/She act as Biostats SMT statistician, provides statistical input in the scientific discussion, participates in the development of study protocols including participation in study design discussions
Job Description
The Senior Biostatistician II is responsible for providing statistical support as assigned. He/She act as Biostats SMT statistician, provides statistical input in the scientific discussion, participates in the development of study protocols including participation in study design discussions. He/She also reviews study setup activities including but not limited to randomization, CRFs and data edits and may serve as primary biostatistician at project level. He/she develops statistical analysis plans including data and report specifications, performs statistical analyses, interprets statistical results, and co-authors clinical study reports. He/she contributes to internal decision making, publications of the clinical data, and integrated summaries for regulatory submissions. Keeps up to date on current methodology research and conducts methodology research driven by project need.

Principal Accountabilities:
1.\tRepresents the statistics function in SMTs to provide statistical expertise and operational insight

2.\tProvides statistical support in the development of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
3.\tAnalyzes and communicates study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.

4.\tExplores alternative analysis methodology and data presentation techniques. Performs modelling and simulations to identify solutions for complex statistical issues.
5.\tSupports the development and implementation of ADS standards. Participates in process improvement initiatives.
Qualifications
*\tPhD in Statistics/biostatistics or equivalent with a minimum of 2-3 years of relevant experiences or Master degree in Statistics/biostatistics or equivalent with a minimum of 3-4 years of relevant experiences
*\tThorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
*\tAbility to provide solutions to a variety of technical problems of moderate scope and complexity.
*\tWorking knowledge of medical/biological terminology and clinical trial designs
*\tProficient in statistical programming languages and software, including SAS, and computing tools for modelling and simulations
*\tWorking knowledge of regulatory guidelines relating to statistical analysis, study reports and statistical components of regulatory submissions.
*\tAttention to details
*\tGeneral project management skills.
*\tEffective oral and written communications.
*\tGood collaborative skills and ability to work with a cross-functional team
Education
PhD or Masters in Statistics/Biostatistics
All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's 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 local government agencies or law.
As an employer of choice, we strive to:
Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organization
Pursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutions
Comply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employment
VEVRAA Federal Contractor
We Request Priority Protected Veteran and Disabled Referrals for all of our locations

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