Senior Manager, Statistical Programming at Eikon Therapeutics

Jersey City, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Clinical ResearchIndustries

Requirements

Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field (e.g., statistics, biostatistics, computer science, or a related discipline)
Proven expertise in SAS and clinical trial programming required; experience in R or Python is a plus
Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards based on quality, compliance, and timeliness requirements
US or worldwide drug regulatory application submission experience including the development of electronic submission deliverables
Experience with CDISC and ADaM standards
Demonstrated success in the assurance of deliverable quality and process compliance
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Recent experience working in the field of oncology preferred
Experience developing and implementing statistical programming standards preferred
Experience developing JReview reports to support medical monitoring preferred
Experience developing AI application or automation system to improve programming efficiency preferred
Strong working knowledge of reporting processes (e.g., SOPs) and statistical computing environments preferred but not required
Minimum of 3 days a week of onsite presence (or more as business needs require) in New Jersey office

Responsibilities

Be responsible for statistical programming deliverables in multi-disciplinary interactions
Provide development, review, and approval for statistical programming documents and oversee vendor programming work to ensure high quality as well as operational excellence
Have in-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, etc.) and apply corresponding knowledge to develop ADaM specifications, SAS programs, and review regulatory electronic submission packages
Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publications
Support statistical programming quality control process and develop functional Standard Operating Procedures (SOPs) and Work Instructions
Support the development of CRFs, edit checks, review of Data Transfer Specifications, and any other collaborations with Data Management function

Skills

Key technologies and capabilities for this role

SASCDISCSDTMADaMDefine.xmlStatistical ProgrammingClinical StudiesRegulatory Submissions

Questions & Answers

Common questions about this position

What is the onsite requirement for this role?

The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in the New Jersey office to ensure effective management, operational excellence, and collaboration.

What are the education and experience requirements?

Candidates need a Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field such as statistics, biostatistics, computer science, or a related discipline.

What technical skills are required for this position?

Proven expertise in SAS and clinical trial programming is required, along with superior knowledge of CDISC standards (SDTM, ADaM, Define.xml, etc.), and experience in R or Python is a plus.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this position?

Strong candidates have experience with oversight and management of statistical programming deliverables for clinical studies, ensuring quality, compliance, and timeliness, plus expertise in developing analysis datasets, tables, and graphics using global standards.

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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