Manager Of Programming, Statistics

Description

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 Senior Director, 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 is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is 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

Requirements

• Master's degree or higher in statistics, mathematics, computer science, or related discipline.

• Minimum of 5 years of experience working within a pharmaceutical or CRO environment, with experience in Phase I, II and III studies, from start-up through closure.

• Demonstrated proficiency in SAS.

• Demonstrated proficiency in development of SDTM, ADaM packages and development of analysis output

• Experience in managing external vendors.

• Thorough knowledge of applicable regulatory rules and guidelines.

• Excellent organizational skills and attention to detail.

• Effective written and verbal communication and interpersonal skills.

• Able to set priorities and juggle multiple projects and demands.

• Able to think critically and independently and be a proactive problem-solver.

• Able to work independently while exercising initiative, flexibility, and sound judgment.

• Strong commitment to ethical standards

• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

• Ability to travel up to 5%

• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees

• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents

• Fertility and mental health programs

• Short- and long-term disability coverage

• Life, Travel and AD&D

• 401(k) Company Match with immediate company vest

• Employee Stock Purchase plan

• Generous vacation plan and paid company holiday shutdowns

• Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.