Vp, Biometrics/ Biostatistics

2 weeks ago

San Diego, United States Kumquat Biosciences Inc Full time

Description:
At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus in Oncology. The biometrics department plays an essential role in innovative clinical trial design and data quality delivery to bring better clinical trials to more patients and ultimately safe and effective drugs.

We want you to join our mission and be part of our passionate and collaborative community, We value individual and team accountability and also see the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional descriptions.

This position reports to the Chief Medical Officer

VP of Biostatistics:
Who you are:
You are a talented and passionate human, inspired by our shared purpose to innovate clinical trial design and deliver life changing drugs to more patients.

You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.

You have strong interpersonal skills and thrive leading or being an active member of large or small diverse teams.

You thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient

Expectations:
Lead Biometrics group

Collaborate closely with Clinical Development to develop the optimal strategies to grow the portfolio and advance development programs

Oversee and lead input and execution of statistical analysis plans and assure statistical and data integrity and accuracy in clinical development plans, clinical protocol, clinical study reports, regulatory documents, publications and presentations

Provide support in working with regulatory responses to regulatory authority questions and preparation for regulatory authority meetings

Contribute to and present analyses to internal and external audiences including Safety Review Committees and independent Data Monitoring

Manage data release, review and participate in in QC and finalization of various documents

Build and resource the Biometrics team while providing leadership to team members including managing performances, developing people, hiring and integrating new team members

Establish best practices, identifying the needs and drive for the creation of standard operating procedures and work instructions.

**Requirements**:

- PhD in Biostatistics or Statistics
- Deep statistical and operational expertise, a proven ability to build and manage fully capable biometrics function
- Understanding of regulatory guidelines for drug development, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- 10+ experience in clinical and drug development in the pharmaceutical/ biotech industry including trial design, regulatory submission/ approval experience and overseeing multiple molecules in various stages of development
- Experience in oncology and hematological malignancies
- Understanding of Phase I to Phase 3 drug development
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Prior people management experience and experience identifying organizational needs (talent, process, technology)
- Expert in the principles and techniques of data analysis, interpretation and clinical relevance
- Expert level of proficiency with SAS and / or other statistical software packages

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