Director of Biostatistics

Clinical  ·    Boston, MA  ·   Fulltime

The Role

In this role, you will utilize your statistical and programming expertise in support of clinical trial programs, regulatory filings, and real world evidence studies. You will be responsible for development of statistical analysis plans and analysis of study data to support regulatory submissions and product commercialization and reimbursement. You will contribute to protocol development, study design and dissemination of findings. You are a self starter who requires minimum supervision and thrives in a fast paced environment.

Responsibilities

• Provide input into the design and execution of studies for regulatory submissions and for reimbursement and commercialization.
• Provide statistical input into clinical study documents (protocol, case report forms, etc.).
• Oversee CRO data management and statistical analysis activities.
• Develop statistical analysis plans and clinical study reports.
• Perform statistical programming of deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs and response to regulatory questions.
  • TMF trial documentation.
  • SAS programs and specifications to generate regulatory compliant deliverables
  • Validation and documentation of SAS programs, CDISC data sets and regulatory output
  • Produce and validate Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE)
• Develop SAS macros, templates and utilities for data reporting and visualization.
• Develop validated SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets.
• Follow best practices in programming documentation.
• Conduct analyses for conference presentations and manuscripts.
• Develop and maintain SOPs and WIs governing statistical analysis, reporting and data management.

Qualifications

• PhD degree in biostatistics, public health or related discipline with 5+ years experience in statistical analysis of clinical trials data or
• MS degree in biostatistics, public health or related discipline with 7+ years of experience in statistical analysis of clinical trials data.
• Experience with modeling and simulation including general linear models, mixed models, multiple comparisons, categorical data analysis, non-parametric methods, multiple comparisons, and missing data analysis.
• Proficiency in SAS statistical programming.
• Knowledge of R required, proficiency is a plus.
• Knowledge of FDA and international regulations and guidelines includingGCPs, SOPs, submissions, and medical device reporting.
• Medical device experience is preferred.
• Experience in cognitive science and/or digital health is preferred.
• Experience driving interactions with external partners and parties such as investigators, CRO’s, and regulatory organizations.
• Strong written and oral communication skills.
• Flexibility, ability to multitask, eagerness to learn, and consummate team player.

About Akili

At Akili Interactive, our mission is to ignite new hope for those living with cognitive impairment. We’re bringing together world-class neuroscience with the latest technology and video game entertainment to create a new class of digital medicines, delivered through captivating video game experiences. We are out to prove that effective medicine for serious illnesses can also be fun and engaging.

Our flagship product, EndeavorRx, is the first ever FDA-cleared prescription treatment delivered through a video game to treat children living with ADHD. This is only the beginning, as we continue to boldly challenge the status quo of today’s medicine.

Diversity and Inclusion

Diversity and inclusion are incredibly important to all of us. We are committed to hearing all voices. Akili Interactive provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, sexual orientation, gender identity or gender expression.

Please click here to apply.