Manager, Statistical Programming
Company: Eisai
Location: Nutley
Posted on: January 27, 2023
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Job Description:
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.Manager, Statistical
Programming sought by pharmaceutical company in Nutley, NJ.Position
based in Nutley, New Jersey, but candidate can telecommute and work
remotely from anywhere in the U.S. Responsible for reviewing SAP,
TLG shells and variable derivation rules and providing feedback.
Review Study Quality Surveillance Plan and Data Monitoring
Committee charter. Implement the monitoring plan set by the
statistician and produces the needed datasets and TLGs. Review the
SAP, provide feedback to the statistician and develop study
specific datasets. Develop programs for the creation and validation
of datasets (SDTM & ADaM) and TLGs. Integrate multiple studies in
support of an ISS/ISE. Support ad-hoc, interim, exploratory,
publications and perform programming and generate outputs. Maintain
data, programs and report in accordance with 21 CFR part 11.
Create/validate the eSubmission components (transport datasets for
both SDTM & ADaM, Annotated CRF, define documents). Manage the
workflow of others to ensure work is done within a given deadline.
Requires: Master's degree (or foreign equivalent degree) in
Biostatistics, Applied Economics, Pharmaceutics, Industrial
Pharmacy, or closely related life science discipline plus 3 years
of experience in job offered or as Clinical SAS Analyst. Also
requires 3 years of experience with/using the following (which may
have been obtained concurrently): SAS Software; SAS Enterprise
Guide; SAS/BASE, SAS/STAT, SAS/MACROS, SAS/ODS, SAS/REPORT, and
SAS/GRAPH; Managing CRO activities and deliveries; Using CDISC
standards (SDTM and ADaM); MedDRA and WHODD. Send resumes to HR
Department, Job Code: R2107, Eisai Inc., 200 Metro Blvd. Nutley, NJ
07110.Eisai requires all new hires to be fully vaccinated against
COVID-19 and provide valid proof of vaccination as of their start
date, to the extent permitted under applicable law. This
requirement is a condition of employment at Eisai, and it applies
regardless of whether the position is located at an Eisai site,
field based or is fully remote. If you are unable to receive the
vaccine for qualifying medical reasons (including
pregnancy-related), or religious reasons (sincerely held religious
beliefs), you will have an opportunity to request a reasonable
accommodation.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 WorkE-Verify
Participation
Keywords: Eisai, New York , Manager, Statistical Programming, Executive , Nutley, New York
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