Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a non-absorbed potassium binder, which is being developed for the treatment of hyperkalemia. The company was formed in 2007 and is based in Redwood City, CA. More information is available at www.relypsa.com.
Patiromer (RLY5016) for Oral Suspension is a high capacity non-absorbed oral potassium binder being developed for the management of elevated serum potassium levels. Relypsa completed the Phase 3 clinical program in 2013.
The Principal Programmer Analyst will provide strong technical statistical programming leadership to the Statistical Programming function within the clinical group and will serve as a technical resource for internal or contract statistical programmer analysts. The position will be responsible for the creation, review and approval of clinical electronic data sets, tables, listings, figures and documentation intended for delivery to a regulatory agency or other designated group, as well as for publications and safety related or ad hoc internal data analyses.
• Promptly respond to internal information requests of clinical data
• Collaborate with functional management across the organization on project deliverables and timelines for projects within area of responsibility
• Ensure consistency in infrastructure within the Clinical Development organization
• Manage department quality requirements in coordination with Regulatory Compliance and IT
• Provide technical leadership for projects within area of responsibility
• Directly contribute to technical development and process improvement within the Clinical Development organization
• Monitor resourcing needs and communicate to senior management resourcing needs necessary to meet corporate goals and timelines
• Recruit /retain, train and manage employees and contractors within area of responsibility
• Work with vendors
• Develop, apply and promote consistent programming standards through standard processes and SOPs
• Identify areas of deficiency requiring SOPs or guidelines and develop and execute a plan to rectify
• Follow guidelines and specifications on validation and data transfer procedures
• Maintain appropriate documentation surrounding maintaining or archiving clinical data and/or programs
• BS/BA/MS in Statistics, Computer Sciences, Mathematics, or Life Sciences (MS is preferred)
• Minimum 8-12 years of experience within the pharmaceutical/biotech development industry or relevant clinical research organization industry
• Experience in the development of analysis files and quality assurance of data
• Experience in programming within a regulated environment
• Experience with integrated summaries (ISE/ISS)
• Experience with developing and reviewing content for Clinical Study Reports and Electronic Submissions
• Experience with overseeing and reviewing the activities of other personnel, consultants, and/or vendors as appropriate
• Experience supporting data analyses used for publications, abstracts and late-breaker oral presentations
• Strong technical background in SAS/BASE, SAS/GRAPH and SAS/STAT
• Experience with the delivery of electronic data and other files to regulatory agencies and other groups
• Facility with working and reporting from data from multiple and varied sources
• Strong working knowledge of the drug development process, including applicable regulations and guidelines
• Strong well-rounded technical experience in implementation and use of CDISC standards within the workplace
• Excellent verbal and written communications skills
• Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• Ability and commitment to working in a fast paced and team-oriented environment
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Relypsa’s high regard for our employees.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa, Inc. is an EOE