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Associate Director, Statistical Programming

Eisai Inc.

Nutley, NJFull-time$200–218K/yrTracked 6 days agoSeen in employer's feed 6 days ago

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At a glance

Compensation
$200–218K/yr
Location
Nutley, NJ
Schedule
Full-time
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Master's degree

Job overview

Associate Director, Statistical Programming sought by Eisai Inc. in Nutley, NJ. Spearheads statistical programming activities for multiple studies, leads programming submission activities, works with the Head of Programming to set standards and improve efficiency, and serves as the go‑to subject‑matter expert for statistical programming issues.

Skills & qualifications

RequiredNice to have

Skills

SAS EGCDISC SDTMCDISC ADaMNDA/BLA SubmissionsISS/ISEeSub RequirementsRegulatory & Compliance Requirements for BiostatisticsCRO Vendor ManagementAlzheimer Disease ResearchNeurology Research

Qualifications

Master's in Molecular and Cellular Biology or Biotechnology or Related8 Years Pharmaceutical Industry Experience in Clinical Development Statistical Programming4 Years CDISC Experience

Full job description

Compensation

$200,091.38 - $217,900.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Job Description

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, and SAS EG. Salary $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.

Place of Work

On-site

Requisition ID

R4048

Job Type

Full Time

Application Instructions

Please send resumes to HR Department, Job Code: (list Job code #R4048) Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110.

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