Senior Director, Biostatistics

About us:

Ventus is a clinical-stage biopharmaceutical company with two novel small-molecule programs entering Phase 2 clinical trials for immunology, inflammation, and neurology therapeutic areas. The two wholly owned programs include VENT-03 a first-in-class, oral cGAS inhibitor expected to be evaluated for lupus and VENT-02 a brain-penetrant, oral NLRP3 inhibitor in development for Parkinson’s disease and osteoarthritis.

Our pipeline is powered by ReSOLVE® - a platform combining the latest advances in AI/ML (machine learning), protein science, structural biology, and biophysics to substantially increase the speed and accuracy of small-molecule drug discovery.

Position Overview:

The Senior Director, Biostatistics will work with cross-functional teams to advance transformative medicines for people with neurological, immunological and inflammatory diseases. The ideal candidate is a dynamic and engaged leader able to lead a growing function of analytical and data sciences, spanning multiple molecules, phases, and trials. The leader must be facile in innovative statistical techniques, able to oversee compliant and high-quality data management and statistical programming, and be willing to be hands-on all in all aspects in our dynamic small company environment. 

The successful candidate will: 

• Be an experienced biostatistician with deep pharmaceutical/biotechnology experience  
• Be a strategic thinker, a strong communicator, high-energy, self-motivated, and forward thinking 
• Have experience working in neurodegenerative and inflammatory diseases (desirable but not required) 

Primary Responsibilities include:  

• Provide statistical strategies and expertise for clinical development, regulatory submission, and patient access data generation for the assigned clinical development program or functional areas  
• Be accountable for all statistical aspects of assigned clinical development programs or functional area, including clinical development plans, protocols, and regulatory submissions 
• Oversee collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of Biometrics or Biostatistics deliverables from internal and external teams (e.g., CRO) that meet their objectives while complying with regulations and quality standards 
• Effectively interact with members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Leads/oversee optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, and to address identified or potential statistical issues arising in studies or programs 
• Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions  
• Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs  
• Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures, and listings 
• Represents Ventus regarding statistical issues with external parties including regulatory agencies and corporate partners 
• Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles 
• Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses  
• Design and specify randomization schedules; review and approve test randomization lists
• Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents  
• Perform ad hoc and exploratory statistical analyses as needed  
• Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results  
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations  
• Contribute or lead standardization and process improvement efforts for Biometrics and contribute to cross-functional process improvement efforts 
• Participates in development and implementation of functional or cross-functional SOPs for process simplification, standardization or improvement 
• Develops and leads a team of high performing biostatisticians to meet corporate, R&D, and program goals 

Desired Education and Skills:  

• Ph.D. in statistics or related discipline with 7+ years, or Master's Degree with 10+ years of experience in the pharmaceutical or biotech industry 
• Experience of providing statistical leadership for clinical development programs  
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials  
• Experience leading NDAs, MAAs or other regulatory submissions  
• In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches  
• Knowledge of FDA, EMA and ICH regulations and guidelines  
• Knowledge of immunology and/or neuroinflammation therapy is desirable, but not required  
• Proficient in statistical programming (SAS and R)  
• Experience with trial design software (e.g., EAST)  
• Ability to concurrently lead statistical efforts for multiple projects 
• Understanding data standards, including SDTM and ADaM  
• Adept at overseeing statistical services provided by CRO's  
• Ability to concurrently lead or coordinate statistical efforts for multiple projects  
• Ability to communicate statistical information to non-scientists, willingness to educate internal team  
• Experience in managing a Biostatistics or Biometrics team and overall resource planning 
• Ability to commute to either Waltham, MA or Montreal, QC on a regular basis #LI-Hybrid