Director, Biostatistics

Company: CRISPR Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

Company OverviewAt CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases ---thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.Job SummaryThe Director of Biostatistics is responsible for leading, developing and implementing statistical solutions to optimally support all phases of clinical trials and decision making. The successful candidate will function as the lead statistician across clinical development programs, and may supervise study level statistician in-house and at CROs and be accountable for all biostatistics study deliverables. The role will include key trial statistician responsibilities including statistical design of all phases of trials, authoring of SAPs, and conducting just-in-time analyses and data exploration. Industry experience is required; experience with regulatory filings strongly preferred.Reporting to the Head of Biometrics, the successful candidate will have the opportunity to take a leadership role in the Biometrics function at CRISPR, and must possess the desire and ability to work with study teams up through and including leadership responsibilities. ResponsibilitiesServe as the lead statistician across clinical development programs Ensure that clinical development programs meet scientific, regulatory, and quality requirementsPerform management of in-house and/or outsourced biostatisticians/programmers, and mentor these team members as requiredPerform trial statistician responsibilities as needed, including attendance of study team meetings, authoring SAPs, reviewing CRFs, design of phase 1-3 and PK studies, review of protocols/amendments, conducting exploratory data analyses, and performing just-in-time analyses Apply innovative statistical approaches to study design, analysis and data exploration methodologiesPlan and track study level activities within programs, including resources; ensure CRO timelines and objectives are metHelp establish and maintain department data standards, within and across programs Serve as a general clinical development and statistical resource; participate in non-clinical project activities. QualificationsPhD in Biostatistics or related discipline with 10 years biopharmaceutical industry experience; MS in Biostatistics or related discipline with extensive industry and leadership experience will be consideredPrior experience in a program statistician role (4 years minimum)Prior manager experience (2 years minimum)Experience with Bayesian methods preferredExperience with regulatory submissions Proven knowledge and expertise in statistics and its applications to clinical trialsFluent with statistical software including SAS, R, EAST, Winbugs, Spotfire among othersAbility to work independentlyFluent in English (oral and written)Excellent communication and presentation skills Team player, with ability to work successfully across functionsAbility to lead and inspire Biometrics teamsInnovative, flexible mindsetSummaryLocation: Cambridge, MA, United StatesType: Full TimeExperience: ExecutiveDepartment: Biometrics

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