Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
SC
Hybrid Principal Biostatistician
Posted 2 months ago
About the role
- Principal Biostatistician focusing on clinical trials with leadership responsibilities at SDC. Guiding junior staff and ensuring quality standards in biostatistics analysis throughout projects.
Responsibilities
- Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members.
- Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department.
- Maintain the statistical and analytical integrity of clinical trials analyzed by SDC.
- Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.
- Support business development and project management with strategic planning, proposals, pricing, and timeline planning.
- Serve as an internal consultant for biostatistics analysis tools and methods.
- Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support.
- Actively support business development in capabilities presentations to prospective and current clients.
- Effectively manage assigned clinical study budgets for biostatistics analysis support.
- Develop, coach and mentor junior biostatistics department personnel.
- Act as the lead statistician on clinical research projects and help with SAS programming.
- Provide statistical expertise for study design of clinical trial protocols.
- Write statistical methods section of the study protocol, as needed.
- Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
- Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
- Program summary tables, data listings and graphical representations of clinical trials data.
- Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data.
- Prepare/review key sections of clinical study reports and various regulatory documents.
- Perform statistical QC of all department outputs including analyses and clinical study reports.
- Provide statistical support to answer questions from external clients (such as FDA, Investigators).
- Contribute to the development, maintenance, and training of standard operating procedures (SOPs).
- Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.
- Manage biostatistics timelines, budgets, and client expectations.
- Adhere to all aspects of the Statistics & Data Corporation’s quality system.
- Comply with Statistics & Data Corporation’s data integrity & business ethics requirements.
- Perform other related duties incidental to the work described herein.
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.
Requirements
- Effective leadership, budget forecast and implementation skills.
- Excellent analytical skills, with the ability to process scientific and medical data.
- Able to work independently and in teams.
- Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills.
- Excellent knowledge of statistical programming.
- Expertise in manipulating and analyzing SAS data.
- Able to identify data issues, present problems, and implement solutions.
- Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients.
- Excellent organizational and time management skills, with the ability to multi-task.
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- Strong interpersonal communication and presentation skills.
- Able to effectively collaborate across cross-functional teams.
- Focus on quality at all times and in all situations.
- Typically a Master’s degree in biostatistics, statistics or other related, scientific field and four years of relevant professional experience; or a PhD in biostatistics, statistics or other related, scientific field and three years of relevant experience; or equivalent combination of experience, education, and/or demonstrated ability.
Benefits
- We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
- We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
- We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
- We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
- With a proven track record, SDC has been successfully executing client clinical programs since 2005.
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