Director, Biostatistics
Company: CRISPR Therapeutics
Location: Somerville
Posted on: January 12, 2021
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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
Keywords: CRISPR Therapeutics, Somerville , Director, Biostatistics, Executive , Somerville, Massachusetts
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