Senior Manager, Statistical Programming

Position

The Senior Manager, Statistical Programming will be responsible for statistical programming deliverables in Eikon clinical studies. In this role, you will report to the Sr. Director, Statistical Programming.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You have experience with the oversight and management of statistical programming deliverables for clinical studies, ensuring that they meet quality, compliance, and timeliness requirements. You are excited to collaborate with various stakeholders including Biostatistics, Clinical Research, Regulatory, Clinical Safety, Data Management, and PK/PD Modeling.

What You'll Do

• 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.

Qualifications

• 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

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.