We are looking for a creative but analytical 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!
What It Entails
- 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.
- Executing, and coaching others in executing, pre-specified analyses to drive clinical validation, and exploratory 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.
What You Need
- PhD or MS in Statistics or Biostatistics.
- 5+ years (for PhD) or 8+ years (for MS) industry experience analyzing clinical trial data, including large multi-site trials, with both objective and subjective outcome measures.
- Demonstrable experience with SAS and R.
- Experience driving interactions with external partners and parties such as investigators, CROs, and regulatory organizations.
- Bonus points for experience teaching statistics or working as a statistical consultant.
Akili – The Company
Akili Interactive (www.akiliinteractive.com) is pioneering the field of digital therapeutics, combining scientific and clinical rigor with the ingenuity of the tech industry to develop novel digital medicines designed to treat cognitive dysfunction and brain-related conditions.
Akili’s flagship product, AKL-T01 in pediatric ADHD, is now under review by FDA for clearance following Akili’s recent filing. Akili previously announced positive top-line results of a multi-center, randomized, double-blind, controlled pivotal study evaluating the safety and efficacy of AKL-T01. If cleared by FDA, AKL-T01 would be the first prescription video game to treat a medical condition and the first prescription digital medicine for children with ADHD. The product is based on technology developed at UCSF that was featured as the cover article in Nature under the headline “Game Changer.”
Akili was founded by leading neuroscientists and top-tier game design veterans to create gaming experiences that are designed to directly treat cognitive deficiency and improve symptoms associated with medical conditions across neurology and psychiatry. Akili has partnerships with top pharmaceutical companies, and has received recent recognition in major media outlets including the Wall Street Journal, CNBC, Fast Company, and The Verge.
- Computer Software
- Information Technology
- Salary Offer 0 ~ $3000
- Experience Level Junior
- Total Years Experience 0-5
- Dropdown field Option 1