The Director Biostatistics will be the statistical lead on Principia clinical development projects. This position will work collaboratively with clinicians, data managers, clinical operations and external CRO statisticians and programmers in the planning, conduct, and analysis of clinical studies in all phases.
Lead the biostatistics function to develop and execute statistical strategy, design, and analyses for clinical trials
Direct the activities and manage external CROs and /or statisticians, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards
Ensure timely delivery CROs of quality analysis results
Provide guidelines and standards to CROs to ensure quality of deliverables
Work with department head and colleagues to develop, implement and maintain internal and outsourced biostatistics department standards and practices
Help design data capture methods and select appropriate study endpoints for clinical programs
Attend meetings with regulatory agencies and support/defend clinical programs
Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data
Be able to conduct independent research and resolve statistical methodological issues
Ensure that the interpretation of data obtained, from trials conducted by CROs is accurate, scientifically sound and credible
Supervise internal and external statistical resources to achieve department functional goals for biostatistics and data management
Responsible for writing statistical methodology section of the protocol, including sample size calculation.
Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE.
Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents to ensure critical variables are collected
Participate in operations meetings and address issues related to biometrics.
Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports.
Perform ad hoc analysis and data validation as needed.
Good knowledge of drug development regulations pertinent to statistical analysis
Experience in contributing to NDAs/BLAs submission and defense successfully with health authorities is preferred
Proficient SAS programming skills and solid understanding of CDISC models and SDTM and ADAM standards
Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills
Extensive knowledge of clinical research methodology and regulatory requirements as they related to trial design and analysis is required; experience in oncology is required.
Good knowledge of ICH, FDA, and GCP regulations and guidelines
Has scientific background and understanding of clinical trials, clinical development operations and regulatory compliance.
Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences
PhD in Statistics, Biostatistics, or related fields;
A minimum of 15 years of experience with at least 3 years of supervisory experience managing an outsourced biometrics function, is preferred
Stakeholder Communication & Management
Drives for Results
Drives Engagement and Decision Quality
Manages Ambiguity and Complexity
Optimizes Work Processes
Continuous Learning and Self-Development
Principia Biopharma, Inc. is an equal opportunity employer
Internal Number: 6
About Principia Biopharma
Principia Biopharma is a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Principia’s proprietary Tailored Covalency® platform enables the Company to design and develop reversible and irreversible covalent, small molecule inhibitors with potencies and selectivities that have the potential to rival those of injectable biologics, yet maintain the convenience of a pill. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 2 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenic purpura, a rare hematological disease. PRN2246, a low dose covalent BTK inhibitor which crosses the blood-brain barrier, is being developed for multiple sclerosis and, potentially, for other diseases of the central nervous system. It has completed dosing in a Phase 1 clinical trial in healthy volunteers and has been partnered to Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor, or FGFR, is being evaluated in a Phase 1 trial in patients with solid tumors.