Director, Biostatistics - Remote
We’re a different kind of biotech company. And we’re here to make a difference.
Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases.
The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Headquartered in San Diego, Prometheus Biosciences, Inc. was named Best Places to Work by Biospace, San Diego Business Journal and is a Great Place to Work-Certified™ Company.
This position will work closely with the Vice President, Biostatistics and other members of the Biometrics team to provide statistical support across all clinical programs. The ideal candidate will provide leadership and statistical input for clinical development programs. This person is 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 to the development of biometrics standards and procedures.
Key Duties and Responsibilities
Lead statistical support to clinical programs as assigned, including but not limited to, 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.
- 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 help 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.
- Provide input on biometrics-related SOPs, work practice documents, and technical standards, as appropriate.
Education and Experience
- Advanced degree in Statistics, Biostatistics, or related discipline. PhD statistics or equivalent is preferred.
- PhD with 6+ years of experience or MS with 8+ years of experience in clinical research for phase I-IV clinical trials in a pharmaceutical/CRO environment.
Skills and Abilities
- Technical knowledge and experience with experimental design, advanced statistical analysis methodology, and simulation.
- Technical knowledge and experience with SDTM, ADaM, and Define.XML.
- Clear 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.
- Strong professional experience in a similar role within the pharmaceutical industry.
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.