What are the responsibilities and job description for the Manager, Programming Statistics position at Viridian Therapeutics, Inc?
At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. 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.
Reporting to the Vice President, Quantitative Sciences, the Manager of Programming, Statistics will be responsible for 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 incumbent 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 may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to):
- 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.
- Monitors and tracks the quality of all statistical programming deliverables ensuring audit practices have been enacted to validate the quality and assurance of statistical content and supporting documents.
- Assist in user acceptance testing of clinical database
- Works cross-functionally, and with CROs to design and develop study documents including development of SDTM and ADaM packages, development of analysis output
- 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
- 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
