Company Description

Equillium Inc is a clinical-stage biotechnology company headquartered in San Diego. Equillium leverages deep understanding of immunology and its role in disease to pioneer new products for severe autoimmune and inflammatory disorders. Equillium is looking for experienced and motivated professionals interested in applying their unique skills to the shared mission.

Overview of Position:

Reporting to the Head of Biometrics, the Associate Director/Director of Biostatistics will lead one or more development programs as the Lead Biostatistician to support clinical trial design, conduct, analysis and reporting. This individual will need to direct, guide, and validate work from CRO team or internal consultants. This individual will provide programming supports to study teams as needed for ad hoc requests and regulatory submissions.  This position will be based in San Diego (2-3 days on site per week) but could be remote for the right candidate.

Essential Duties & Responsibilities:

• Author clinical trial protocol sections including study objectives, endpoints, sample size, stratification, randomization, and analyses; defend the study designs and analyses to Equillium’s partners and regulatory authorities when required.
• Keep current on statistical literature in areas related to Equillium’s business and apply the best available statistical methods to clinical studies conducted or sponsored by Equillium.
• Review and provide appropriate input to the design of Case Report Forms.
• Provide written statistical analysis plans for each study assigned and ensure that appropriate statistical methods are utilized.
• Support and manage interim analysis and Data Monitoring Committee activities. 
• Monitor the conduct of clinical trials and perform quality control with respect to the data to be analyzed and the programs to be used for the analysis.
• Oversee CRO statistician and programmers to ensure timelines meeting and quality deliverables, validate vendor outputs regularly.
• When needed, lead and manage statistical programming activities to ensure quality and timelines, perform hands-on programming activities, review programming documentations, and lead programming efforts in regulatory submission and post-submission responses.
• Support development of SOP, process, and standards for Biostatistics and Statistical Programming.
• Ensure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical Trials.

Job Requirements:

• Minimum education/experience designing and analyzing clinical trials:
• M.Sc. in Statistics/Biostatistics or other quantitative fields plus 7 years’ experience
• Ph.D. in Statistics/Biostatistics or other quantitative fields plus 3-7 years’ experience
• Thorough knowledge of statistical and clinical trial methodology
• Strong technical skills in statistics and/or programming including familiarity with CDISC/SDTM requirements
• Proficiency with commonly used statistical software including SAS
• Previous experience within the pharmaceutical industry and in oncology trials (early or late  phases)
• Ability to set priorities, multi-task and interface with team members who are working under deadlines
• Thorough work habits combined with strong analytical skills, ability to gather critical information, and demonstrate compliance with all relevant standards and requirements
• Possess and display professional integrity, interpersonal awareness, adaptability, flexibility, and initiative
• Be willing to continuously seek for improvement in work quality and efficiency 
• Excellent organizational planning and time management skills