Job Description
The Principal Statistician is responsible for developing statistical solutions to optimally support all phases of clinical trials and decision making. The successful candidate will function as the study statistician and be accountable for study level deliverables. The role will assume key trial statistician responsibilities including statistical design, authoring of SAPs, overseeing production of analysis datasets and statistical outputs, and conducting just-in-time analyses and data exploration. Industry experience is preferred.
Key Responsibilities:
- Serve as study statistician across development programs
- 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, overseeing production of analysis datasets and statistical outputs, supporting regulatory filing as necessary, 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 company data standards, within and across programs
- Serve as a general clinical development and statistical resource at the company
Qualifications:
PhD in Biostatistics or related discipline with 3+ years biopharmaceutical industry experience; MS in Biostatistics or related discipline with 6+ years biopharmaceutical industry experience will be considered
Experience with Bayesian methods preferred
Proven knowledge and expertise in statistics and its applications to clinical trials
Fluent with statistical software including SAS, R, EAST, WinBUGS among others
Motivated with ability to work independently
Excellent communication and presentation skills
Team player with ability to work successfully across functions
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.
