Director/Senior Director, Biostatistics KAI Pharmaceuticals

KAI Pharmaceuticals, located in South San Francisco, is a clinical-stage, biopharmaceutical company whose lead peptide product candidate, KAI-4169, is in development for the treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Building on promising, early-stage clinical data, KAI is working towards advancing KAI-4169 into Phase 3 clinical development in end-stage renal disease (ESRD) patients on dialysis. The company is in need of a strategic yet hands-on Director/Senior Director, Biostatistics to provide leadership and guidance in support of Phase 3 clinical ramp up activities.

Specific Responsibilities include (but not limited to):

Apply complex and innovative statistical approaches to assigned work (e.g, modeling and simulation, adaptive design statistics) and mentor staff in the use of these approaches.

Participate in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions.

Execute the statistical analysis plans (SAP) in support of clinical development programs, with a primary emphasis in support of our phase 3 study.

Prepare the statistical methods and results sections for clinical study reports and overall summaries; this responsibility includes review of protocols and CRFs for soundness of trial design.

Supervise development, documentation and validation of standard programs.

Interface with biostatistics resources, primarily CROs, to manage timelines, milestones, and finances in relation to CRO management.

Serve as a biostatistics expert for research, design, analysis, reporting, and presentation of sophisticated statistical analysis and methods for clinical studies.

Maintain strong knowledge of regulatory guidance including Good Clinical Practice, therapeutic area clinical guidelines, statistical guidelines, quality of life and patient reported outcomes.

Collaborate with Clinical Development, Clinical Operations, Biometrics, Regulatory and CMC and represents the Biostatistics function on the integrated project teams.

Develops statistical programs as necessary to perform analyses, prepare data displays, and verify data accuracy and validity from clinical trials and other sources.

Plan and implement staffing, contracting, budgeting, project scheduling, departmental processes.

Manage aspects of all clinical projects to ensure that they have an optimal opportunity to meet their objectives while complying with regulatory rules and guidelines.

Participate in assessment and selection of CROs/external contractors. Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the statistical aspects are outsourced.



Requirements:

MS or PhD in Biostatistics, Statistics or related field.

At least 10 years in pharmaceutical industry with clinical trials experience including Phase 1- 3, Phase 2 & 3 experience strongly preferred.

Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it to all phases of clinical trials.

Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing.

Prior experience in supervising other statisticians; capable of supervising programming and data management resources.

Prior experience in the preparation of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions.

Adept at outsourcing and managing biostatistical services provided by CROs and/or contractors.

Proficiency in strategizing, planning, monitoring and problem solving.

Experience in being a leader contributing to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies of different types for multiple projects is required.

Computer skills and habits appropriate for working in a regulated environment.

Ability to work in a small, dynamic company environment.

Location:	270 Littlefield Avenue South San Francisco, CA 94080 United States