Location: Boston, MA
We are looking for an analytical Senior/Principal Biostatistician to focus on design and analysis of randomized clinical trials to join our growing team. Your experience combined with existing talented team, will allow us to enjoy the challenges and promise of a growing and innovative company in the new Digital Medicine space.
Specific duties include:
- Clinical trial design and analysis planning for multi-site randomized controlled trials (RCTs) on the path towards FDA registration and commercialization of novel medical device interventions for cognitive disorders.
- Evaluating psychometric properties of clinical outcomes and internal device metrics, especially as pertains to disease populations, and the appropriate statistical methodologies to apply to answering questions with them.
- Pre-specifying analyses to drive clinical validation, and executing post hoc analyses to inform product development and testing, including hypothesis generation for further validation.
- Working with Clinical Research Organizations (CROs) to ensure company analytical goals are adequately addressed throughout the lifecycle of a trial, including data capture, management, and cleaning.
- Ensure that accurate, timely results are communicated clearly to stakeholders with terminology and context appropriate for the audience.
- PhD in Statistics or Biostatistics
- 5 years industry experience analyzing clinical trial data, including large multi-site trials, ideally with both objective and subjective outcome measures.
- Demonstrable experience wth SAS and R.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Experience driving interactions with external partners and parties such as investigators, CRO's, and regulatory organizations.
Reasonable accommodations may be made to enable individuals with disabilities.
Akili is an equal opportunity employer that embraces diversity and inclusion.