Head (Sr. Director) of Biometrics
Calithera is seeking a Head of Biometrics to build and lead the Biometrics function. This will include the oversight of Biostatistics (providing strategic technical leadership and guidance on the design and conduct of clinical studies) and of the Programming and Data Management functions. The ideal candidate will be adept at interacting with various groups both within the company and external to the company.
Calithera is focused on discovering and developing small molecule drugs that slow tumor growth through controlling key metabolic pathways in the tumor and immune cells.
Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients. Our investigational onco-metabolism medicines take advantage of the specific metabolic requirements of tumor cells and cancer-fighting immune cells.
Calithera’s discovery and development efforts are focused on diseases for which new treatments are urgently needed for patients suffering from renal cell carcinoma, triple negative breast cancer and other tumor types.
Duties and Responsibilities:
- Develop and implement department standards and practices to ensure statistical integrity of project deliverables.
- Direct the statistical design, conduct, and analysis of clinical trials in all phases.
- Review protocols and case report forms for soundness of trial design.
- Review and or author statistical analysis plans for all phases of a trial.
- Perform and/or review the analysis and interpretation of clinical study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Ensure that the interpretation of data obtained from clinical trials, is accurate, scientifically sound and credible
- Direct the development, validation and summary of integrated safety and efficacy summaries.
- Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
- Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
- Provide strategic and operational oversight of the Programming and Data Management function, to include managing external vendors and/or building an internal team.
- Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
- Partner to develop department standards to ensure statistical integrity of project deliverables.
- Provide guidance and expertise to the clinical development team regarding biostatistics related subject matter.
- Develop departmental metrics and tracking systems for statistical analysis plans and data quality assurance.
- Stay abreast of emerging technologies and concepts related to applied statistical methodology
Qualifications and Requirements
- Ph.D. in Statistics or Biostatistics with 10+ years of direct experience in biotechnology industry.
- In-depth knowledge of statistical analysis methods and results/data presentation formats of oncology clinical data.
- Advanced knowledge of statistical methods in clinical study designs, clinical data analyses.
- Experience in design and development of statistical analysis plans, study protocols, clinical study reports.
- Experience with NDA/BLA filings, preferably as the lead statistician for the filing.
- Great knowledge of clinical operations, data management, and clinical study report preparation workflow.
- Experience with oversight of the Programming and Data Management functions.
- In-depth knowledge of regulatory regulations and guidelines.
- Clear and effective communication skills to present complex data to project teams including non-statisticians and easy for others to interpret and understand.
- Excellent interpersonal communication skill to build relationship cross-functionally and collaborate effectively.
- Strong leadership skill, problem solver and ability to influence business stakeholders on key decision-making process.
- Proficiency in MS Word, Excel, PowerPoint, and Project.
Calithera Biosciences, Inc.is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.