Imara Inc.: Head Of Biometrics

Position SummaryImara 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.

In this newly created role, the Head of Biometrics will report directly to the Chief Medical Officer.

The successful candidate will lead our statistical, data management, and programming teams and develop a well-coordinated and collaborative function at Imara.

Essential Duties and Responsibilities Establish and lead high-performing statistics, statistical programming, and data management teams to support clinical development activities with a focus on quality and excellenceOversee all biostatistics, statistical programming, and data management activities including strategy, program support, personnel oversight, best practices, compliance, timely study deliverables and application of emerging scienceAssure that activities comply with health authority regulations, ICH/GCP guidelines and company SOPsLead a team to develop and implement statistical and statistical programming strategies and solutions to support all phases of clinical trials and decision makingServe as the lead on clinical development programs to support the product development team to design and support study analyses, interpretation of efficacy, safety data, and biomarker dataProvide oversight of statistics, statistical programming, data management, and support activities of external vendors to ensure timeliness and quality of analysis data and statistical outputsApply innovative approaches to study design, analysis, data modelling and exploration, and presentation methodologiesLeads development of department SOPs and best working practice guidesIdentify study-level vendor requirements and participate in the evaluation/selection of analytical vendorsAuthor relevant sections of regulatory submissions and represent Imara at regulatory agencies and participate in writing, review and finalization of abstracts and manuscripts for publicationRepresent Imara on data safety monitoring boards to oversee clinical studiesDevelop and retain key talent by managing and mentoring biostatisticians, programmers, data managers, and others including contract personnel as needed to grow and foster a cohesive teamEducationAdvanced degree in Biostatistics, Applied Mathematics (including statistics) or related biometrics discipline.

PhD preferred Experience, Knowledge, Skills and AbilitiesAt least 10 years of experience in the pharmaceutical or biotechnology industry, preferably in rare disease; including at least 3 years of prior management experienceRobust knowledge of the pharmaceutical industry and clinical drug development processIntimate knowledge of clinical study designs including innovative approaches with adaptive designs, common analysis methods, descriptive and inferential statistics, knowledge of clinical biomarker and diagnostic development statistics, summarization of data and presentation practicesLeadership experience in both early and late-stage development and contributing to governance milestones, strategy, health authority interactions, protocols and submissionsProven track record of effective leadership including managing reports, teams, taskforces or initiativesExperience in CDM, including databases, EDC platforms, data imports/integrations, and standards including CDISC, SDTM, CDASHWorking knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics and data handlingSound knowledge of statistical programming languages (including SAS), software.

Working knowledge of UNIX operating systems and common software products and technologies used in conjunction with SAS (e.G., Microsoft Office products)Experience with outsourcing biometrics activities and overseeing services provided by CROs and contractors preferredExcellent oral and written communication skills Team player, with ability to work successfully across functionsEmbodies the Imara values and seeks to inspire others to do so Ability to work on-site at our Boston office a few times a month and occasionally more as the business needs Level will be commensurate with experience Imara is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics.

In addition to federal law requirements, Imara complies with applicable state and local laws governing nondiscrimination in employment.