Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
The Associate Director, Statistical Programming serves the critical role for providing lead and oversight to programming team/activities. Assist in 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.
Assist in managing 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
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
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 years relevant experience 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 JOB REQUIREMENTS: Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaults<img height=1 width=1 border=0 src=https://eisai.contacthr.com/73358952.jpg /> To apply for this position, please copy and paste the following link into your browser address bar: https://eisai.contacthr.com/73358952
Preferred Years Of Experience:10 Year(s)
Education Required:Masters Degree - MA
Employment/Position Type:Full Time
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