Location: Boston, MA
We are looking for a creative but analytical Senior/Principal Biostatistician join our growing team to help us design and analyze randomized controlled trials to validate innovative digital treatments and assessments for cognitive disorders. The new Digital Medicine space holds great promise, but comes with an array of novel challenges along the path to FDA registration and commercialization of Software as a Medical Device (SaMD). With positive results in hand, we look to combine your experience with our existing talented team to push the envelope on redefining what medicine can be!
Specific duties include:
- Clinical trial design and analysis planning for multi-site RCTs at various phases of our SaMD pipeline.
- Evaluating psychometric properties of clinical outcomes and internal device metrics, and the appropriate statistical methodologies to apply in answering questions with them.
- Pre-specified analyses to drive clinical validation, and post hoc analyses to inform product development and testing, including hypothesis generation for further validation.
- Working with Clinical Research Organizations (CROs) to address the company's analytical goals throughout the lifecycle of a trial, including data capture, management, and cleaning.
- Ensuring that accurate, timely results are communicated clearly to stakeholders of all types.
- 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, CROs, and regulatory organizations.
Reasonable accommodations may be made to enable individuals with disabilities.
Akili is an equal opportunity employer that embraces diversity and inclusion.
To apply for this position, contact us through Puretech Health.