Director Biostatistics

Eisai; Nutley (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

An innovative pharmaceutical company is seeking a Biostatistician to play a pivotal role in clinical development. This exciting position involves designing clinical trials, performing data analysis, and collaborating with various teams to ensure regulatory compliance. The ideal candidate will have extensive experience in biostatistics and a strong understanding of the pharmaceutical industry. Join this forward-thinking organization to contribute to groundbreaking research in neurology and oncology, making a significant impact on patient care and health outcomes. If you're ready to thrive in a fast-paced environment and drive change, this opportunity is for you.

Qualifications

• PhD with 10+ years or MS with 15+ years of experience in biostatistics.
• Proven excellence in clinical development and CRO oversight.

Responsibilities

• Designs clinical trials and performs data analysis for regulatory submissions.
• Leads global registration trials and ensures quality of CRO deliverables.

Skills

Biostatistics

Communication & Cross-functional Influence

Critical Thinking & Business Agility

Industry/Regulatory Knowledge

Mentoring/People Development

Project Management

Statistical Programming

Vendor Management

Education

PhD in related fields

Master's degree in related fields

Bachelor's degree in Life Sciences

Tools

SAS

R programming

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.

This position plays a critical role within clinical development, responsible for designing clinical trials, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets, and coauthoring manuscripts. The role also involves working with statisticians on process development, internal contractor oversight, and various team management and development tasks.

Job Summary

This position plays a critical role within clinical development, responsible for designing clinical trials, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets, and coauthoring manuscripts. Additionally, it involves collaboration with statisticians on process development, contractor oversight, and team management.

Essential Functions

1. Reviews protocols and study documents: Collaborates with business alliances, leads interactions on statistical discussions, and supports regulatory submissions. (30%)
2. Provides statistical support: For clinical trials and drug development plans, working with clinical, project management, and data teams on study design, reviewing and approving study documents, performing analyses. (10%)
3. Influences statistical practices: Contributes to departmental standards and guidelines within Eisai's Neurology group. (10%)
4. Ensures quality of CRO deliverables: Works with internal and external statisticians and programmers for quality assurance. (10%)
5. Leads global registration trials: Manages all related statistical activities as the lead statistician. (10%)
6. Prepares regulatory inputs: For documents and meetings, and responses to health authorities, including new analyses. (10%)
7. Assesses analytical strategies: Identifies team training needs and recommends solutions. (10%)
8. Supports operational efficiency: Provides strategic input for process improvements in Biostatistics. (10%)

Requirements

• PhD with 10+ years or MS with 15+ years of experience in related fields or pharmaceutical/CRO environment.
• Proven excellence in biostatistics across multiple areas, with broad understanding of clinical development.
• Experience with CRO oversight and FDA submissions preferred.
• Excellent technical writing and communication skills.
• Strong teamwork, initiative, and organizational skills.
• Proficiency in SAS or R programming.

Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in the Life Sciences industry is preferred.

Skills include: Biostatistics, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry/Regulatory Knowledge, Mentoring/People Development, Project Management, Statistical Programming, Vendor Management.

Eisai is an equal opportunity employer and commits to diversity in hiring, training, and promotion without regard to race, color, religion, gender, age, national origin, citizenship, marital status, sexual orientation, gender identity, disability, or veteran status. We also prohibit discrimination against persons with disabilities, including disabled veterans.

Eisai participates in E-Verify, an online system to verify employment eligibility of new hires in the U.S. For more information, please see the provided link.