Associate Director, Statistical Programming

Eisai US•Nutley, NJ

20h•$166,000 - $217,900

About The Position

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. 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. Associate Director, Statistical Programming sought by Eisai Inc. in Nutley, NJ. Spearhead the statistical programming activities for multiple studies and lead the programming submission related activities. Work with the Head of programming to establish standards for programming and establish efficiency within the group. Serve as the key "go to" Subject Matter Expert for all Statistical Programming issues. Drive the success of 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. Requirements: A Master's degree in Molecular and Cellular Biology, Biotechnology, or closely related plus 8 years of experience in Pharmaceutical industry experience in clinical development statistical programming methods and processes in job offered or related roles. Also requires 4 years’ experience with/using the following (which may have been gained concurrently): CDISC expertise (SDTM and ADaM). NDA/BLA submissions, ISS/ISE and eSub requirements. Regulatory & Compliance Requirements for Biostatistics processes. Management of CRO vendors within a matrixed environment. Alzheimer Disease and Neurology research study experience SAS EG The base salary range for the Associate Director, Statistical Programming is from $200,091.38 - $217,900.00. Under current guidelines, this position is eligible to participate in: Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Employees are eligible to participate in Company employee beneﬁt programs. Please send resumes to HR Department, Job Code: (list Job code #R4048) Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110. Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management, Statistical Programming Skills, Vendor Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Statistical Programming is from :$166,000-$217,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter. 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. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.

Requirements

A Master's degree in Molecular and Cellular Biology, Biotechnology, or closely related plus 8 years of experience in Pharmaceutical industry experience in clinical development statistical programming methods and processes in job offered or related roles.
CDISC expertise (SDTM and ADaM).
NDA/BLA submissions, ISS/ISE and eSub requirements.
Regulatory & Compliance Requirements for Biostatistics processes.
Management of CRO vendors within a matrixed environment.
Alzheimer Disease and Neurology research study experience
SAS EG

Responsibilities

Spearhead the statistical programming activities for multiple studies and lead the programming submission related activities.
Work with the Head of programming to establish standards for programming and establish efficiency within the group.
Serve as the key "go to" Subject Matter Expert for all Statistical Programming issues.
Drive the success of 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.