Associate Director, Statistical Programming

Eisai•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.
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

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.