Senior Biometrics Informatics Consultant

Job Title:

Senior Biometrics Informatics Consultant

Job Function:
Compliance SME

Location:

Redwood City, CA - Hybrid

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Work with Clinical Data Management, Statistical Programming, Biostatistics, and Clinical Pharmacology to envision, evaluate vendors, purchase, configure or build, and validate a new Statistical Computing Environment (SCE) that enables our Client to scale support for its growing clinical portfolio.

• Lead requirements gathering and vendor evaluation for a new Statistical Computing Environment.
• Develop the current-state system and interface map and create the vendor-selection scorecard.
• Coordinate pilots, vendor selection, and purchasing activities.
• Lead solution configuration, implementation, and validation with internal teams and vendors.
• Serve as the technical lead and subject-matter expert throughout implementation and handover.

• Performs other related duties and assignments as required

• Five or more years leading or supporting Statistical Computing Environment implementations in the drug-development industry.
• Experience leading vendor selection and implementation of validated systems in biotech or pharmaceutical environments.
• Strong knowledge of SAS and R programming practices in clinical development.
• Experience gathering requirements from Biostatistics, Statistical Programming, and Clinical Pharmacology teams.
• Experience working in GxP environments, including computer system validation and SOP-driven processes.
• Clinical data standards experience.
• Experience with AI-assisted SAS or R coding.

• Bachelor’s degree in Computer Science or Information Systems or related field.
• Master’s Degree preferred

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration…