Caidya · 18 hours ago
Principal Biostatistician
United States
Full-time
Remote
Senior Level, Lead/Staff
7+ years expCaidya is seeking a Principal Biostatistician who is experienced in leadership and client engagement within the clinical development lifecycle. The role involves providing biostatistical services for global trials, representing Biostatistics during proposal development, and collaborating with cross-functional teams.
BiotechnologyClinical TrialsMedicalmHealthTherapeutics
Responsibilities
Proven written and oral communications with regulatory agencies
Special expertise in more complex statistical analytical methods not well known to all biostatisticians
Established expertise in a medical therapeutic area
Established a long-term high-level relationship with a Company sponsor
Overall high-quality work and a strong reputation for statistical knowledge
Exhibited leadership and organizational skills to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials
Demonstrated ability to adapt and adjust to changing priorities and deal with uncertainty and risks
May be given some supervisory responsibilities for junior staff or department areas
Qualification
Required
PhD or Master's in statistics or related area, or equivalent degree globally
PhD + 7-10 years (or MS + 10 years) experience in pharmaceutical, CRO, or related environment
Excellent written and oral communication skills including technical writing of all statistical results
Ability to develop professional presentations for presenting statistical issues and solutions to clients internally
Ability to effectively learn and handle new or unfamiliar statistical methods
Ability to find needed written resources and interact with other Biostatics staff with the needed familiarity
Willingness to share expertise with junior staff members
Excellent broad ranging understanding of statistical methods and issues
Demonstrates leadership in several areas of statistics
Has a developed expertise in 1-2 therapeutic areas
Ensures statistical quality: Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team
Deep working knowledge of clinical drug development process: In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts
Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics
Develops capability for interacting with regulatory agencies on behalf of sponsor matters
Ability to write statistical reports and/or present oral arguments to regulatory agencies
Ability to serve as a Project Manager for GCA studies
Coordinate keeping tasks and project activities in line with agreed timelines and budget
Excellent training and presentation skills
Strong understanding of departmental and company procedures which relate to tasks that are performed routinely
Strong understanding of all departmental SOPs and good understanding of all required company SOPs
Familiarity with Company Functional Areas that Biostatistics interacts with on a regular basis
Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings
Company
Caidya
Caidya is a clinical research organization that provides personalized solutions for various therapeutic areas.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$165MKey Investors
Rubicon Founders
2025-01-13Private Equity· $165M
2023-04-17Series D
Leadership Team
George Baeder
Advisor To Chief Executive Officer
Lingshi Tan
Chairman & CEO
Recent News
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