Eikon 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. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
The Senior Manager, Statistical Programming will be accountable for statistical programming deliverables in Eikon clinical studies. In this role, you will report to the Sr. Director of Statistical Programming.
You will oversee and manage the statistical programming deliverables for clinical studies, ensuring that they meet quality, compliance, and timeliness requirements. The role requires collaboration 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, oversight 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
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 8 years SAS programming experience in a clinical trial environment; or MS with a minimum of 6 years relevant work experience
- Expertise in SAS and clinical trial programming; Experience in R 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 and worldwide drug regulatory application submission experience including the development of electronic submission deliverables
- Experience in 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 but not required
- Experience developing and implementing statistical programming standards preferred but not required
- Experience developing JReview reports to support medical monitoring preferred but not required
- 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 $152,000 to $175,000 depending on skills, competency, and the market demand for your expertise.