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 protocol development, statistical analysis plan preparation, and regulatory submission.
Responsibilities
Supervise project planning and execution.
Coordinate with Statistics, Programming, and Data Management functions to ensure contracted scopes and plans are communicated in a timely manner.
Supervise Project Management function to ensure smooth and prompt response to customer’s and internal team’s requests. Identify issues and escalate to senior management as needed.
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.
Supervise monthly project progress and units tracking. Troubleshoot contract, budget, and invoice issues.
Supervise contract workflow from start to finish. Ensure prompt contract upload to the D365 system and timely invoice.
Provide statistical consulting to:
Clinical study design, protocol development, and sample size calculation.
Develop statistical analysis plan for clinical study, participate in data analysis activities, and review clinical study reports.
Participate in regulatory submission strategy discussion, prepare integrated analysis plans, and review submission documents.
Conduct statistical methodology research and stay current on statistical methodology and drug development.
Identify and provide solutions to statistical issues.
Qualifications
Education
Master’s or Doctoral degree in statistics or biostatistics
Experience
12-18 years of relevant experience in a health sciences research institute or pharmaceutical/biotech industry, including minimum of 6 years of supervision experience
10 years plus, of experience in management of scientific projects
Skills
Understanding of proposal, contract and budget processes
Detail-oriented and excellent organizational skills
Excellent written and verbal communication skills.
Leadership qualities including the soft skills needed to build collaboration and cross functional teamwork across the organization.
Deep understanding statistical concepts and methodology related to clinical trials and drug development.
Comprehensive knowledge on regulatory guidelines
Physical
Must be able to work in an office environment, which has minimal noise conditions.
Ability to stand or sit for most of the workday.
Must be able to perform some activities with repetitive motion, such as keyboarding
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.
La Jolla, California
Other