Overview

The primary responsibility of this position is to supervise proposals, contracts, and budget activities, as well as oversee the planning and execution of biometrics’ projects. This position will also provide statistical expertise to statistical analysis plan preparation and execution.

Responsibilities

• Project planning and execution.

• Coordinate with Project Managers, Statisticians, Programmers, and Data Managers to ensure contracted scopes and plans are communicated in a timely manner.

• Ensure smooth and prompt response to customer’s and internal team’s requests. Identify issues and escalate to senior management as needed.

• Oversee the scope and budget of change orders to ensure appropriateness.

• Manage contracts, budget, and customer’s request- for-proposals (RFP) and request-for-information (RFI).

• Coordinate activities to respond to RFP and RFI. Define project scopes and estimate the budget for the proposals.

• Troubleshoot contract, budget, and invoice issues.

• Supervise contract workflow from start to finish, and ensure timely invoice.

• Provide statistical expertise for clinical study projects.

• Develop statistical analysis plan for clinical study, participate in data analysis activities and client meetings, and review clinical study reports.

• Serve as lead study statistician and interact with programming and data management functions for deliverables. Identify and provide solutions to statistical issues.

• Review the derivations of key ADaM variables, data specifications, and inferential statistical programming code for accuracy.

• Conduct statistical analyses as needed.

Qualifications

• Master’s degree in statistics or biostatistics

Experience

• 8 years plus, of relevant experience in a health sciences research institute or pharmaceutical/biotech industry

• 6 years plus, of experience in management of scientific projects

Skills

• Understanding of proposal, contract and budget processes

• Detail-oriented and excellent organizational skills

• Strong project management skills supporting technical customers.

• Excellent written and verbal communication skills.

• Leadership qualities including the soft skills needed to build collaboration and cross functional teamwork across the organization.

• Comprehensive understanding on general statistical methodology related to clinical trials and drug development.

• Comprehensive knowledge on regulatory guidelines.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Job Locations US-CA-San Diego

Job ID 2024-13290