Imara is a clinical stage company committed to developing novel therapeutics for hemoglobinopathies. With IMR-687’s ease of administration and stable properties, our goal is to develop and deliver therapies to serve a broad range of patients suffering from hemoglobinopathies around the world, including those in underserved regions.
As Sr. Biostatistician/Principal Biostatistician you will be responsible for the statistical support on assigned clinical studies and can serve as a leader on specific projects. The successful candidate will have a strong understanding of drug development and will work effectively cross functionally across Imara and with external vendor partners.
Essential Duties and Responsibilities
As a Sr. Biostatistician, act as the lead or contributing statistician on one or more individual studies, and associated project teams. A Principal Biostatistician would have responsibility at the program level.
As a Sr. Biostatistician, provide statistical input into all phases of clinical development (ensuring regulatory compliance and compliance with good statistical practice) and provide statistical input into the reporting of clinical trial results: CSRs, manuscripts, regulatory submissions, and presentations to Congresses
As Principal Biostatistician, produce and deliver statistical analysis strategy for clinical development programs (including target product profiles), clinical development plans, endpoint strategy, statistical analysis plans (SAPs), reports and manuscripts, and statistical analysis required to support development programs.
Provide statistical input into protocol and CRF development (e.g., trial design, sample size determination and power analysis, randomization, statistical methods for protocols, and edit checks for clinical trial data), annual safety reporting, and development and updating of program level investigator brochures.
Author/review statistical analysis plans for studies, and author/edit shells for tables, listings and figures.
Analyze clinical trial data and produce accurate results that represent the outcome of the trial, validate statistical outputs, and accurately interpret and clearly communicate statistical results and concepts to non-statisticians.
Perform ad hoc and exploratory statistical analyses as needed
Oversee, manage, and QC CRO statistical and programming activities to ensure quality deliverables within timelines.
Author/review DMC charter and serve as an internal independent statistician for assigned clinical trials.
Education and Experience
PhD in Statistics or related fields with a minimum of 2 years of experience or master’s degree with at least 4 years of experience, or equivalent combination of education and clinical trial experience.
Knowledge, Skills and Abilities
Working Knowledge of FDA, EMA, and ICH guidance for drug development
Excellent working knowledge of CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in STDM, ADaM, and SEND data standards and associated documentation.
Excellent presentation skills to interpret statistical concepts and results to clinical development team.
Proficient in SAS programming and at least one other programming language such as R for statistical analysis.
Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required.
Excellent verbal and written communication skills
Detail and process-oriented.
Must be able to demonstrate strong project management skills.
Good organizational skills, ability to multi-task in a fast-paced environment with changing priorities
Ability to work on-site at our Boston office a few times a month and occasionally more as the business needs