Description

Reporting to the SVP, Head of Biometric Sciences, the Executive Director will be responsible for managing biostatistical 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 the biostatistics 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):

• Ensure that Company Research and Development projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and life cycle management of existing products
• Assume accountability for biostatistical components of regulatory submissions; Ensure activities are conducted in compliance with relevant regulatory requirements
• Provide biostatistics subject matter expertise to the clinical development teams as appropriate; Liaise with non-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues
• Lead and supervise an efficient and effective biostatistics team. Manage performance of direct reports, ensure development and succession planning. Provide coaching and feedback to foster professional development while also supporting business goals
• Facilitate and maintain communication between biostatistics and cross-functional areas to include Clinical Research, Clinical Operations, data management, Regulatory Operations, Pharmacovigilance, Medical Affairs, etc. translating strategic decisions into operational plans.
• Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed
• In partnership with key members of the biostatistics department, lead development and optimization of biostatistical related SOPs and templates with specific focus on efficiency and quality, while maintaining or exceeding industry best practices. Influence the broader organization with respect to innovation in clinical study design and/or analysis methods
• Establish and maintain external relationships with biostatistics community, key opinion leaders and other external biostatistical consultant
• Develop and maintain a culture of innovation in study design, analytic methods, and execution optimization
• Define, drive and prepare (or supervise preparation of) statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g. Briefing Books, NDA/CTD, Regulatory Responses, Advisory Committee preparation, etc.)
• Understand the compliance environment and drive collaboration with the compliance team. Maintain inspection readiness of all biostatistical deliverables
• Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients as our top priority

Requirements

Qualifications:

• Requires a PhD degree in statistics or biostatistics with 15+ years of relevant work experience in pharmaceutical industry OR a Master's degree in statistics or biostatistics with 20+ years of relevant pharmaceutical industry experience.
• 10+ years of experience of direct management of internal and/or external biometrics team highly preferred
• Proven excellence in biostatistics and clinical development plan strategy, operations, and execution
• Extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the global drug development process. eCTD NDA submission experience is a must
• High degree of proficiency with SAS statistical procedure and specialized relevant statistical software (e.g. EaST, R, etc.)
• Ability to lead a team with regards to ongoing development both personnel development and departmental methodologies and techniques
• Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently; Able to work in a quickly changing matrix environment
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Strong verbal and/or written communications skills
• 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
• Competitive medical, dental, and vision insurance
• 100% Paid Parental Leave
• 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 fertility, mental, financial, and proactive physical health programs