Sr. Statistical Programmer

Description

Kodiak 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 Responsibilities

• Assist 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 documents
• Write, 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 needed
• May serve as a technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed
• Work with internal stakeholders to gather requirements and write specifications
• Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables
• Write macros for reusability
• Review and verify vendor deliverables for quality and accuracy
• Contribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documents
• Interface with outsourcing partners and vendors

Education & Experience

• B.S. preferably in Mathematics, statistics, computer sciences or other related field
• 5+ years of clinical trials experience in pharmaceutical or biopharmaceutical setting or equivalent

Additional Skills

• Thorough knowledge of the drug development and regulatory submission cycle
• Excellent project management skills
• Excellent communication skills
• Able to work in a fast pace and agile environment
• In-depth and current knowledge of regulatory requirements and guidance
• Excellent SAS and CDISC skills
• Proficiency in MS Word, Excel, PowerPoint, and Project