Job summary
Job post source
This job is directly from Eisai U.S. Neurology
Job overview
The Director Biostatistics at Eisai U.S. Neurology leads statistical design and analysis for clinical trials, impacting drug development and regulatory submissions in neurology.
Responsibilities and impact
The role involves designing clinical trials, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating datasets, coauthoring manuscripts, managing statisticians, and improving biostatistics processes.
Experience and skills
Requires a PhD with 10+ years or MS with 15+ years in pharmaceutical biostatistics, experience with clinical development, CRO oversight, FDA submissions, strong SAS or R programming, and excellent communication skills.
Work environment and culture
Eisai emphasizes a fast-paced, innovative environment focused on unmet medical needs and teamwork with a commitment to diversity and inclusion.
Company information
Eisai is a growing pharmaceutical company specializing in neurology and oncology, known for developing innovative medicines including a leading Alzheimer's treatment.
Unique job features
The position is distinguished by its critical role in global registration trials, strategic influence on statistical standards, and leadership in regulatory document preparation.
Company overview
Eisai U.S. Neurology is a division of Eisai Inc., the American subsidiary of the global Japanese pharmaceutical company Eisai Co., Ltd., focused on developing and commercializing innovative therapies for neurological disorders such as Alzheimer's disease and epilepsy. The company generates revenue primarily through the research, development, and sale of prescription medications, including notable products like Leqembi (lecanemab) for Alzheimer's and Fycompa for epilepsy. Eisai has a longstanding commitment to human health care (hhc), emphasizing patient-centric approaches and strategic collaborations, including partnerships with Biogen and other biotech firms. Candidates should be aware of Eisai's significant role in advancing neurology treatments, its robust clinical pipeline, and its reputation for ethical research and global impact. The company values scientific innovation, collaboration, and a mission-driven culture aimed at addressing unmet medical needs in neurology.
How to land this job
Position your resume to highlight your extensive experience in biostatistics, clinical trial design, and data analysis, emphasizing your ability to lead global registration trials and regulatory interactions within neurology clinical development.
Emphasize your skills in overseeing CRO activities, validating TLGs and analysis datasets, and your expertise in SAS or R programming, as these are critical for the Director Biostatistics role at Eisai U.S. Neurology.
Apply through multiple platforms including Eisai's corporate career site and LinkedIn to maximize your application visibility and ensure you meet all submission guidelines.
Connect with current Eisai U.S. Neurology biostatisticians and clinical development team members on LinkedIn; use ice breakers such as commenting on recent Eisai neurology research breakthroughs or asking about their experience managing CRO relationships and regulatory submissions.
Optimize your resume for ATS by incorporating keywords from the job description like 'clinical trial design,' 'regulatory submissions,' 'CRO oversight,' 'statistical analysis plan,' 'SAS,' and 'R' to improve the chances of passing initial automated screenings.
Utilize Jennie Johnson's Power Apply feature to automate tailored resume customization, multi-channel application submissions, and LinkedIn networking outreach, allowing you to focus your energy on interview preparation and strategic career moves.
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