Principia Biopharma is a clinical stage biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, we are comprised of a team of exceptionally talented scientists and business leaders. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities.
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
• Team Builder
• Stakeholder Communication & Management
• Cultivates Innovation
• Drives for Results
• Strategic Thinking
• Ensures Accountability
• 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.