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.
The Associate Director position will spearhead the statistical programming activities for multiple studies and will lead the programming submission related activities. Additionally, this position will work with the Head of programming to establish standards for programming and establish efficiency within the group.
Will serve as the key "go to" Subject Matter Expert for all Statistical Programming issues in a highly specialized yet collegial corporate environment where as Associate Director, Statistical Programming. Plays an integral role in driving the success of our key projects and deliverables.
Significant areas of oversight include SAS programming activities in support of Multiple Studies (Phase II -IIIB) for a single or multiple compounds within related therapeutic areas spanning inception through to submission.
- Collaborates 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
- Reviews global submission activities including cross company projects. Acts as a programming functional and technical lead to support submission strategy planning, regulatory communication
- Leads key business objectives or projects within the department; Leads development and updating company policies/SOPs; Recommends enhancements for improvement
- Manages 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
- Master's Degree in relevant field and 8+ years of statistical programming experience in clinical development or equivalent
- CDISC expertise is a must
- Submission, ISS, and ISE expertise
- Advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
- Solid leadership skills, including management of people resources, FTEs, Contractors, and/or CRO vendors within a matrixed environment.
- Experience in assigned TA is required.
- Experience in clinical development statistical programming methods and processes in industry setting required.
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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