Manager, Statistical Programming

Company: Eisai
Location: Nutley
Posted on: January 27, 2023

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