At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary:
Performs statistical analysis on data related to product development in a research and development environment. Uses statistical software such as SAS, SPSS, and other software to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. Creates analysis datasets, assesses quality of data analysis programs, and develops automated analysis tools where appropriate. May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians, clinicians, medical services and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.
Job Summary
The position serves the critical role for providing direction and oversight to programming team/activities. Managing liaisons across the company, with external alliances, vendors, and with regulatory agencies. The position will also be responsible for providing input into submission strategies and will support process and infrastructural improvement, resource and cost management for multiple oncology clinical studies/programs.
Essential Functions
- Manages collaborations with external alliances for all programming related activities. Ensure successful and effective coordination and communications
- Manages, reviews and / or executes statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies
- Leads global submission activities including cross company projects. Acts as a programming functional and technical expert to support submission strategy planning, regulatory communication
- Sets and leads key business objectives or projects within the department; Leads development and updating company policies/SOPs; Recommends enhancements for improvement
- Manages and leads development and enhancement towards standardization and process for consistency, efficiency and accuracy
- Supports computer infrastructure improvement with data integrity by working with internal resources and external vendors
- Participates in recruitment activities; Supports planning and directing work between internal resources and external vendors
- Manages CROs and contractors with regarding the compliance, deliverable qualities, timelines and budgets
Requirements
- Minimum of a Master degree in Biostatistics (preferred), Statistics, computer science, or related discipline. Bachelor degree with extensive experience might also be considered.
- At least 10-12 years relevant experience in statistical programming in the pharmaceutical industry/CRO environment with people and project management experience.
- Highly experienced in clinical development statistical programming methods and processes in industry setting required.
- Regulatory submission experiences in the area of Oncology indications. Have lead programming activities involving CDISC SDTM, ADaM, eSub.
- Experience with CRO oversight.
- Strong organizational skills with ability to effectively manage multiple studies/projects.
- Excellent technical writing and verbal communication skills.
Minimum of a Master degree in Biostatistics (preferred), Statistics, computer science, or related discipline. Bachelor degree with extensive experience might also be considered. At least 10-12 years relevant experience in statistical programming in the pharmaceutical industry/CRO environment with people and project management experience.
Skills:
Budget Management, Clinical Acumen (Oncology), Focus On Customers & Partners, Inquiry Resolution
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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