VP of Biometrics

Location
San Diego, California, United States
Posted
Jun 03, 2021
Ref
o6mHffw8
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Prometheus is a San Diego-based public biotechnology company pioneering a precision medicine approach to the discovery, development, and commercialization of novel therapeutics and companion diagnostic products for the treatment of inflammatory bowel disease (IBD). The company's precision medicine platform, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal multiomics databases to identify novel therapeutic targets and companion CDx approaches that will enable tailored treatments based on molecular patient stratification


SUMMARY


Responsible for the leadership, oversight, and execution of biometrics deliverables for development strategy, clinical development plan, and clinical trials. This individual will lead and oversee all biometrics functions for all phases of clinical trials, regulatory submissions, and business development data evaluations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Provide leadership to all aspects of biometrics including biostatistics, statistical programming, and data management
  • Collaborate with internal R&D functions in clinical development strategy and trial design
  • Oversee and provide hands-on support to ensure the statistical integrity of analysis and reporting deliverables, including statistical methods, optimization of study designs, endpoint selection, authoring and reviewing documents, and oversight of timelines and study level tasks pertaining to statistical analysis and reporting.
  • Serve as the internal expert in quantitative science for complex decision making, clinical trial design, execution, data collections, and analysis.
  • Oversee and manage biometrics vendors in data collection and statistical analysis
  • Responsible for final data check and data integrity of all outward-facing materials
  • Build data science function and infrastructure
  • Attend scientific and external trainings or meetings as needed.


SUPERVISORY RESPONSIBILITIES

TBD.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE
  • PhD in biostatistics or statistics with experience in clinical development in inflammatory bowel disease
  • 15+ years of biopharmaceutical industry experience is required and 10+ years management experience
  • Subject matter expert with an exceptional command of statistics and modern clinical trial designs
  • Have demonstrated a track record of having led the biometrics team in data collection, analysis and reporting
  • Have demonstrated a track record of supporting global regulatory submissions, interacting with FDA and other regulatory authorities
  • Experience programming in SAS, R, and other relevant statistical software solutions
  • Unquestionable integrity and highest ethical standards
  • Strong presence with excellent written and verbal communication skills
  • Self-motivated, assertive, driven, and hands-on leader
  • Ability to operate collaboratively with colleagues across functional areas in an entrepreneurial and science-driven environment
  • Ability to forge solid personal and professional relationships with key opinion leaders and investigators


WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts.

The noise level in the work environment is usually quiet.

Travel up to 25% may be required.