What are the responsibilities and job description for the Associate Director, Statistical Programming position at Eisai US?
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):
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
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
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
Salary : $166,000 - $217,900