Eikon Therapeutics · 3 days ago
Senior Manager, Statistical Programming
Jersey City, NJ
Full-time
Onsite
Senior Level
$157K/yr - $171K/yr
6+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The Senior Manager, Statistical Programming will be responsible for overseeing statistical programming deliverables for clinical studies, ensuring quality, compliance, and timely delivery while collaborating with various stakeholders.
BiotechnologyHealth CareLife ScienceMedical
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
Qualification
Required
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
Preferred
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
Benefits
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
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
Renaissance Capital
2026-01-11
Renaissance Capital
2026-01-11
General Catalyst
2025-12-26
Company data provided by crunchbase