CRISPR Therapeutics Director, Biostatistics in Cambridge, Massachusetts
The 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.
Serve as the lead statistician across clinical development programs
Ensure that clinical development programs meet scientific, regulatory, and quality requirements
Perform management of in-house and/or outsourced biostatisticians/programmers, and mentor these team members as required
Perform 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 methodologies
Plan and track study level activities within programs, including resources; ensure CRO timelines and objectives are met
Help 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.
PhD 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 considered
Prior experience in a program statistician role (4 years minimum)
Prior manager experience (2 years minimum)
Experience with Bayesian methods preferred
Experience with regulatory submissions
Proven knowledge and expertise in statistics and its applications to clinical trials
Fluent with statistical software including SAS, R, EAST, Winbugs, Spotfire among others
Ability to work independently
Fluent in English (oral and written)
Excellent communication and presentation skills
Team player, with ability to work successfully across functions
Ability to lead and inspire Biometrics teams
Innovative, flexible mindset
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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