Senior Manager, Statistical Programming

Eisai US

Nutley (NJ)

On-site

USD 138,800 - 182,200

Full time

14 days+

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Benefits offered by this job

Annual Incentive Plan
Employee benefits

Job summary

Eisai US in Nutley, NJ seeks a Senior Manager, Statistical Programming to lead SAS programming activities across multiple studies within therapeutic areas. You will manage projects, develop datasets, and generate Tables, Listings, and Graphs in line with SAP.

The role requires strong SAS, CDISC (SDTM/ADaM), vendor management, and experience in Phase I/II programming; mentoring and cross functional collaboration are expected.

Qualifications

  • Experience in clinical development statistical programming methods & processes
  • Experience leading projects in Phase I & II studies
  • Significant CDISC SDTM/ADaM experience
  • Vendor management experience and influence
  • Proven performance in prior roles/ similar roles

Responsibilities

  • Manage one or more statistical programming projects and collaborate with cross-functional teams
  • Develop and review codes, create datasets and TLs/Graphs/Listings per SAP
  • Review SAPs for own projects and participate in implementation
  • Collaborate with Biostatistics, Data Management, Clinical Ops to ensure data integrity
  • Identify and monitor external partners/vendors and ensure quality of deliverables
  • Improve processes, systems and training within the team
  • Mentor less experienced team members

Skills

SAS programming
CDISC SDTM/ADaM
Vendor management
Biostatistics
Project management
Mentoring
Cross-functional communication
Leadership
Statistical programming

Education

Bachelor's degree in CS/biostatistics/related
Master's degree in statistics/biostatistics

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.

The Sr. Manager, Statistical Programming is responsible for SAS programming activities supporting multiple studies for a single, or multiple compounds within related therapeutic areas. Programming experience from inception through submission in related areas.

Responsibilities
  • Manage one or more statistical programming projects, working closely with cross functional teams and vendors to ensure timely delivery of high quality output
  • Develop and review codes, create datasets and summary Tables, Graphs, and Listings (TLGs) to summarize the data as per Statistical Analysis Plan
  • Review statistical analysis plans for own projects and contribute to implementation
  • Collaborate cross functionally with teams like Biostatistics, Data Management, Clinical Ops etc. to ensure accuracy of datasets and summary, resolve any issues in project implementation and act as a representative of statistical programming team in study team meetings
  • Participate in the identification and selection of external partners/ vendors and monitor the quality of deliverables
  • Continuously work towards improving statistical programming capabilities within team by improving processes, systems/ tools and training of team members
  • Mentor less experienced members of the team
Qualifications
  • Bachelors / Masters degree in computer science, public health, biostatistics, statistics or other related area 8+ yrs (for Bachelors degree)/ 5+ yrs (for Masters degree) of experience in clinical development statistical programming methods & processes preferably in a pharmaceutical/ CRO/ academia or related environment OR equivalent combination of education and experience
  • Experience driving results indirectly by influencing others
  • Significant experience in vendor management
  • Significant experience in SAS (required)
  • Some experience having led projects pertaining to Phase I & II studies
  • Significant experience in CDISC (SDTM/ADaM)
  • Proven performance in earlier role/ comparable role
Skills
  • Biostatistics 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 Senior Manager, Statistical Programming is from :$138,800-$182,200 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Benefits
  • Employees are eligible to participate in Company employee benefit programs.
  • Certain other benefits may be available for this position.

For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.

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.

Right To Work E-Verify Participation At Eisai Inc., human health care (hhc) is our goal.

As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.

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