Director, Biostatistics

Company Summary:

Atavistik Bio is a privately-held clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Our proprietary AMPS™ platform allows us to rapidly unlock functional cryptic pockets across a broad range of target classes to accelerate the development of groundbreaking medicines. We have rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery. 

Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management. 

Position Summary

We are seeking a Sr. Director of Biostatistics. Reporting to the Chief Medical Officer. In this position you will be acting as the statistical lead for one program or multiple programs, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will have oversight of the statistics and programming team through an outsourced model. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity. 

Key Responsibilities

• Key contributor on regulatory submissions and communication with global regulatory authorities
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of  clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
• Oversee and lead the vendor/CRO biostatistics and programming teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks  
• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses , and providing analyses for publications
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs