DescriptionReporting to the Executive Director, Head of Modeling and Simulation, the Associate Director will play a key role in advancing the Modeling and Simulation function within Biometric Sciences. The role is responsible for leading hands-on modeling and simulation initiatives that support quantitative decision-making across clinical development programs. The Associate Director will develop, apply, and continuously enhance modeling approaches, including clinical trial simulation, innovative statistical methodologies, and disease specific models, to inform study design and portfolio strategy. The position will also drive the implementation of technical capabilities, computational infrastructure, and analytical workflows that improve the efficiency, scalability, and impact of modeling and simulation activities. In partnership with Biometrics Sciences this position will also provide cross-functional analytical support to departments such as Clinical Pharmacology and Scientific Communications.
This role may be based in our Waltham, MA headquarters, 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):- Build, manage, and analyze a scalable, well-curated clinical-trial data repository by integrating raw and standardized datasets (e.g., SDTM, ADaM), harmonizing metadata, and incorporating relevant external/public data sources to support advanced statistical modeling, machine-learning analyses, and cross-study research
- Support multiple departments across the organization by delivering advanced quantitative and analytical expertise, including but not limited to:
- Biostatistics: Provide analytical support for evaluating and selecting optimal study designs, leveraging simulation-based methods to maximize probability of technical and operational success
- Clinical Development: AI solutions to support efficient data review from on-going clinical programs
- Clinical Pharmacology: Conduct and support analyses of pharmacokinetic (PK) and pharmacodynamic (PD) data, including model informed drug development (MIDD) approaches and exposure-response evaluations
- Scientific Communications: Generate analytical inputs and data driven insights to support the publication strategy, including figures, tables, and quantitative summaries for abstracts, posters, and manuscripts
- In collaboration with Head of Modeling and Simulation, contribute to the development and continuous optimization of biostatistical SOPs and templates to enhance efficiency and quality while meeting or exceeding industry best practices. Drive organizational innovation in clinical study design and analytical methodologies
- Contribute to strategic external collaborations within the biostatistics community, key opinion leaders, and external biostatistical consultants to strengthen scientific rigor and support innovation across the organization
- Drive a culture of innovation in study design, analytical methodologies, and operational execution to advance scientific rigor and organizational efficiency
- Promote a strong "ONE Team" culture across all functions by fostering collaboration and a unified focus on delivering the best outcomes for patients
Requirements- Requires a PhD degree in statistics, biostatistics or related field with 6+ years of relevant experience or MS degree with 10+ years of relevant experience
- Expertise in statistical computing languages and infrastructure (R, python, HPC, git, etc.)
- Experience in clinical trial study design optimization through simulation methods to characterize study design performance
- Expertise in statistical modeling related to clinical trial analysis and portfolio decision-making including but not limited to Bayesian modeling, joint modeling, GLMs, estimands, multiple comparisons, adaptive design analysis, and benefit risk
- High proficiency in the analysis of large data sets utilizing machine learning and large language models
- Manage a broad set of activities with competing and aggressive timelines, prioritize activities, and work independently; Able to work in a quickly changing 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 a matrix 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.)
- 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 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
