Associate Director, Statistics

Description

At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases.  We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. 

The Associate Director, Statistics is responsible for statistical and statistical programming activities across multiple studies and programs from study start-up through study closure to ensure completion per established project team goals and objectives. The role will report to the Sr Director of Quantitative Sciences and will work closely with a cross-functional team, and contract research organizations (CROs) in a fast-paced, high growth environment to ensure that clinical data and statistical analysis are complete, high quality, and delivered on time and within budget. This position will manage all statistical activities including statistical programming from CRF design through clinical study report for in-house and outsourced clinical trials with minimal supervision. 

This role is fully remote. Travel to headquarters for meetings may be required at the discretion of management. 

Job Responsibilities:

• Independently lead and represent Viridian Quantitative Sciences for all statistical activities including statistical programming of an assigned study or assigned studies across programs. 
• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures. 
• Establish rapport and maintain positive, open communication with internal Viridian and external third-party teams.
• Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data and associated analyses are complete, accurate and delivered within agreed timelines.
• Will review upcoming deliverables and forecast resourcing requirements as needed to execute ongoing and upcoming activities within timeline and budget requirements.
• Participate in reviewing requests for proposals (RFPs) and providing budgetary, contractual and scope of work (SOW) feedback for the statistical and statistical programming functional area at Viridian.
• Monitors and tracks the quality of all statistical and statistical programming deliverables ensuring audit practices have been enacted to validate the quality and assurance of statistical content and supporting documents.
• Serve as the primary point of contact for Statistical functional area for assigned studies at Viridian.
• Assist in user acceptance testing of clinical database and/or IRT systems.
• Works cross-functionally, and with CROs to design and develop study documents including CRF review, protocol deviation plan, development of randomization lists, development of statistical analysis plan, development of SDTM and ADaM packages, development of analysis output and review of clinical study report.
• Participates in ongoing cross-functional data reviews throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies
• Review  and approve analysis data transfers (i.e. SDTM, ADaM) and other statistical deliverables 
• Participate in cross-functional discussions in relation to study design/execution.
• Generate and disseminate project status reports to management.
• Participate in quantitative science initiatives such as evaluate technology vendors (i.e. analytic tools), author and review SOPs, and establish data analysis standards 

Requirements

• Master's degree or higher in statistics, mathematics, computer science, or related discipline.
• 8+ years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II and III studies, from start-up through closure.
• Demonstrated proficiency in SAS or R.
• Demonstrated proficiency in statistical processes including but not limited to CRF review, development of randomization lists, development of statistical analysis plan, development of SDTM and ADaM packages, development of analysis output and review of clinical study report.
• Experience in managing external vendors.
• Thorough knowledge of applicable regulatory rules and guidelines.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Able to set priorities and juggle multiple projects and demands.
• Able to think critically and independently an