South San Francisco Categories:
Head of Statistics & Clinical Data Management KaloBios Pharmaceuticals
The Head of Statistics & Clinical Data Management will oversee the Statistics and Clinical Data Management function at KaloBios and will report to the Chief Medical Officer. In this role, the ideal candidate will ensure that all systems, data and information systems supporting the clinical development processes and corporate infrastructure are fully validated and functional. Additionally, this person will supervise all contract and CRO counterparts in Statistics and Data Management.Responsible for the statistical and data management aspects of all programs including planning execution, analysis and reporting
Propose and implement continual improvements in methodology, technology, and study process procedures
Participate in the development and review of clinical proposals, budget work ups, presentations, and special projects
Manage the CRO functions of statistics, biometrics and clinical data management
Work with the Head of Quality to continually update project systems, Standard Operating Procedures, project specific procedures, group-wide training programs and study specific plans
Assist in or lead integration planning with KaloBios partners
Provide critical input into advancing KaloBios or contract vendor Electronic Data Capture applications
Work directly with KaloBios CMO for development and implementation of KaloBios Medical Affairs and Clinical Research goals and initiatives
Support and train end-users of biometrics systems
Research courseware, hardware, and software and recommends appropriate choices for implementation
Attend, participate and lead monthly and quarterly project team meetings or Managers-Directors-Vendors Meetings
Leads validation (hardware/software) teams (CTMS and SAS developed data capture systems)
21 CFR Part 11 Compliance advocate
Other duties as assigned by the CMO
Job Requirements:
BS/MS/PhD in biostatistics or related field
10+ years direct data management experience in the biotechnology, pharmaceutical or medical device industry overseeing data management deliverables
Experience managing a Data Management Services Group
Experience managing multiple direct reports, Data Managers and biostatisticians
Must be able to coach a diverse group of employees, identify critical milestones, and hold individuals and teams accountable for strategic objectives
Experience and oversight of both a paper-based system and electronic capture system
Advanced computer skills and analytical skills required
Travel, as necessary, to support client meetings and business development
Ability to work successfully with multi-disciplinary project teams
Outstanding organizational, communication, negotiation and presentation skills
| Location: | South San Francisco, CA United States |
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KaloBios Pharmaceuticals
Investors: 5AM Ventures, Alloy Ventures, MPM Capital, Sofinnova VenturesAll Jobs: at KaloBios Pharmaceuticals
| Web Site: | www.kalobios.com |
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| Headquarters: | 3427 Hillview Avenue Palo Alto, CA 94304 United States |
| Industry: | Biotechnology |
