Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.
Summary
This position is responsible for the leadership, strategy and implementation of all aspects of biostatistics, programming, and data management across all clinical programs. Accountable for statistical design of clinical trials, statistical input and authoring of study protocols and statistical analysis plans, and execution and quality of statistical analyses. The position will require hands-on skills for statistical analysis and validation support to clinical projects and will oversee external vendors to ensure timely and accurate deliverables. This role will also provide statistical expertise for the development of biometrics standards and procedures.
Responsibilities
- Lead statistical support to clinical programs, including strategic input to clinical development programs and regulatory interactions, accountable for statistical design and analysis of clinical studies and implementation of statistical analyses and TFLs.
- Oversight of programming and data management groups
- Collaborates with Clinical Development, Regulatory, Clinical Operations, and Data Management during the study setup and execution, including review of CRFs, IRT specs, UATs, data transfer agreements, DMC charter and statistical plan.
- Provide guidance and review of SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation.
- Provide oversight to external vendors (e.g., CROs) and coordinate statistical and programming activities to meet quality standards and timelines.
- Provide hand-on statistical analysis and validation for statistical deliverables.
- Provide statistical consultation with Research, Bioinformatics, Clinical Pharmacology and Medical Affairs.
- Create biometrics-related SOPs, work practice documents, and technical standards, as appropriate.
Experience and Qualifications
- Ph.D in Statistics, Biostatistics or related discipline with 15 or more years of experience leading biostatistics function for phase I-IV clinical trials in biotech, pharmaceutical industry and/or CRO environment.
- Experience building a team of Biostatisticians, Programmers and Data Management
- Technical knowledge and experience with experimental design, advanced statistical analysis methodology, and simulation.
- Technical knowledge and experience with SDTM, ADaM, and Define.XML.
Skills and Abilities
- Strong understanding of the drug development process, regulatory guidance, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
- Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
- Ability to effectively communicate and perform in a high demand and dynamic working environment.
- Well organized with the ability to multitask, prioritize, and manage complexity and shifting responsibilities in a dynamic, collaborative, cross-functional teamwork environment.
- Must have strong interpersonal and organizational skills and excellent verbal and written communication skills.
The expected base pay range for this position is $275,000 – $325,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.
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