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 SVP, Biometric Sciences, the Executive Director, Statistical Programming will be responsible for managing 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 statistical programming team and the associated activities from CRF design through clinical study report for in-house and outsourced clinical trials with minimal supervision.
This role may be based in our Waltham, MA headquarters (preferred) or remote. Employees local to our office are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to): - Lead the statistical programming team to ensure that resources (processes, procedures, personnel etc) optimally support the business requirements of the function
- Ensure the department has a well-organized infrastructure and adequate resources to enable projects to be completed on time and within budget
- Independently lead and represent Viridian Biometric Sciences for all statistical programming of an assigned study or assigned studies across programs
- Accountable 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 manage internal statistical programmers, oversee contracted vendors, or vendor groups within CRO, to ensure data and associated analyses are complete, accurate and delivered within agreed timelines
- Monitor and track the quality of all statistical programming deliverables ensuring audit best practices have been ensure the quality and assurance of statistical content and supporting documents are validated
- Support 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, data presentation plans
- Management of all ongoing cross-functional data reviews throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies
- Accountable for the approval and traceability of analysis data transfers (i.e. SDTM, ADaM) and other statistical deliverables
- Provide regular status reports of portfolio level deliverables from statistical programming function to senior management
- Participate in Biometric sciences initiatives such as evaluate technology vendors (i.e. analytic tools), author and review and revise SOPs, and establish data analysis standards
RequirementsQualifications: - Requires a minimum of a Master's degree or higher in statistics, mathematics, computer science, or related discipline with 15+ years of experience working within a pharmaceutical or CRO environment
- Experience in all phases of studies in clinical development from start-up through closure
- Demonstrated successful leadership in managing a statistical programming group
- Demonstrated proficiency in SAS
- Demonstrated proficiency in development of SDTM, ADaM packages and development of analysis output
- Experience in development of a statistical computing environment that meets regulatory requirements
- Experience in managing external vendors
- Thorough knowledge of applicable regulatory rules and guidelines
- Excellent organizational skills and attention to detail
- Excellent written and verbal communication and interpersonal skills
- Able to set priorities and manage 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 20%
- 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
• Competitve medical, dental, and vision coverage
• 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.
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 SVP, Biometric Sciences, the Executive Director, Statistical Programming will be responsible for managing 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 statistical programming team and the associated activities from CRF design through clinical study report for in-house and outsourced clinical trials with minimal supervision.
This role may be based in our Waltham, MA headquarters (preferred) or remote. Employees local to our office are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to): - Lead the statistical programming team to ensure that resources (processes, procedures, personnel etc) optimally support the business requirements of the function
- Ensure the department has a well-organized infrastructure and adequate resources to enable projects to be completed on time and within budget
- Independently lead and represent Viridian Biometric Sciences for all statistical programming of an assigned study or assigned studies across programs
- Accountable 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 manage internal statistical programmers, oversee contracted vendors, or vendor groups within CRO, to ensure data and associated analyses are complete, accurate and delivered within agreed timelines
- Monitor and track the quality of all statistical programming deliverables ensuring audit best practices have been ensure the quality and assurance of statistical content and supporting documents are validated
- Support 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, data presentation plans
- Management of all ongoing cross-functional data reviews throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies
- Accountable for the approval and traceability of analysis data transfers (i.e. SDTM, ADaM) and other statistical deliverables
- Provide regular status reports of portfolio level deliverables from statistical programming function to senior management
- Participate in Biometric sciences initiatives such as evaluate technology vendors (i.e. analytic tools), author and review and revise SOPs, and establish data analysis standards
RequirementsQualifications: - Requires a minimum of a Master's degree or higher in statistics, mathematics, computer science, or related discipline with 15+ years of experience working within a pharmaceutical or CRO environment
- Experience in all phases of studies in clinical development from start-up through closure
- Demonstrated successful leadership in managing a statistical programming group
- Demonstrated proficiency in SAS
- Demonstrated proficiency in development of SDTM, ADaM packages and development of analysis output
- Experience in development of a statistical computing environment that meets regulatory requirements
- Experience in managing external vendors
- Thorough knowledge of applicable regulatory rules and guidelines
- Excellent organizational skills and attention to detail
- Excellent written and verbal communication and interpersonal skills
- Able to set priorities and manage 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 20%
- 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
• Competitve medical, dental, and vision coverage
• 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.
