Vice President, Biostatistics

$275,000 - $325,000/Yr

Mirador Therapeutics, Inc. - San Diego, CA

Full-time - Executive

San Diego, CA

About the position

The Vice President of Biostatistics at Mirador is responsible for leading the strategy and implementation of biostatistics, programming, and data management across all clinical programs. This role involves overseeing the statistical design of clinical trials, authoring study protocols, and ensuring the quality of statistical analyses. The position requires hands-on statistical analysis skills and oversight of external vendors to ensure timely and accurate deliverables, while also providing statistical expertise for 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.
• Collaborate with Clinical Development, Regulatory, Clinical Operations, and Data Management during study setup and execution.
• 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 hands-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.

Requirements

• 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.
• 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.

Nice-to-haves

• Familiarity or experience with R Software.

Benefits

• Bonus
• Equity
• Comprehensive benefits