Job at a glance
DescriptionKodiak Sciences Inc. is a rapidly growing, clinical-stage biopharmaceutical company dedicated to transforming ophthalmology through innovative therapeutics. Our proprietary Antibody Biopolymer Conjugate Drug (ABCD) platform integrates protein engineering, polymer chemistry, small molecule drug discovery, and advanced drug delivery technologies to address prevalent and debilitating retinal diseases with the goal of improving patient outcomes worldwide.
In this fast-growing and fast-paced organization, your expertise is needed to provide support for clinical and statistical programming activities related to multiple clinical studies.Key ResponsibilitiesAssist in the review of key study-related documents produced by other functions, e.g. Statistical Analysis Plan, Case Report Forms, Data Management Plan, Database Specifications, EDC Data Structures, DMC plans and other clinical documentsWrite, test and validate SAS programs to produce analysis datasets, TLFs, to be included in reports for submission to regulatory agencies, publications and other communications as neededMay serve as a technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as neededWork with internal stakeholders to gather requirements and write specificationsInteract and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverablesWrite macros for reusabilityReview and verify vendor deliverables for quality and accuracyContribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documentsInterface with outsourcing partners and vendorsEducation & ExperienceB.S.
preferably in Mathematics, statistics, computer sciences or other related field5+ years of clinical trials experience in pharmaceutical or biopharmaceutical setting or equivalentAdditional SkillsThorough knowledge of the drug development and regulatory submission cycleExcellent project management skillsExcellent communication skillsAble to work in a fast pace and agile environmentIn-depth and current knowledge of regulatory requirements and guidanceExcellent SAS and CDISC skillsProficiency in MS Word, Excel, PowerPoint, and Project