STRAGO Healthcare is a global talent acquisition advisory specialising in the healthcare and life sciences sectors. We partner with leading organisations to connect them with exceptional professionals worldwide, ensuring access to top-tier talent that drives innovation, enhances patient care, and accelerates advancements in the industry.
The Opportunity:
Asa Principal Biostatistician ,you will play a pivotal role in the design, implementation, and analysis of clinical trials. You will work closely with the Head of Biostatistics and collaborate with multidisciplinary teams, including clinical operations, medical affairs, and regulatory affairs, to ensure the highest levels of scientific rigor, regulatory compliance, and data integrity.
This position offers the opportunity to lead a diverse range of statistical projects, provide technical guidance, and contribute to the strategic execution of statistics projects across various therapeutic areas. You will be integral to providing expert statistical insight into study protocols, statistical analysis plans, and data reporting, contributing to the advancement of cutting-edge clinical research.
Key Responsibilities:
- Lead Statistical Analysis:Design, implement, and oversee statistical analyses for clinical trials, ensuring they meet regulatory and scientific standards.
- Collaborate with Cross-Functional Teams:Work closely with clinical operations, regulatory affairs, medical affairs, and other stakeholders to provide statistical expertise and ensure seamless project execution.
- Study Design and Sample Size Calculation:Contribute to the statistical sections of clinical protocols, providing recommendations for study designs, sample size calculations, and statistical methodologies.
- Operational Guidance:Provide technical and operational leadership to biostatistics teams and mentor junior statisticians, ensuring that all statistical work is executed in line with the company's Standard Operating Procedures (SOPs) and industry best practices.
- Regulatory Compliance:Ensure all statistical work complies with GCP guidelines, regulatory requirements, and industry standards, including CDISC and other relevant frameworks.
- Data Integrity and Reporting:Oversee the statistical analysis and reporting of clinical trial data, ensuring high levels of data integrity, validity, and transparency in reporting results to internal and external stakeholders.
- Stakeholder Engagement:Engage with clients and external partners to provide expert statistical input and ensure high-quality service delivery that meets client expectations and regulatory standards.
- Innovation and Best Practices:Stay up-to-date with the latest advancements in biostatistics, clinical trial methodology, and regulatory requirements, integrating new techniques and tools as appropriate to improve the quality and efficiency of statistical processes.
Position Requirements:
- Educational Background:Minimum of a Master's degree in Biostatistics, Biometrics, or a related field (Ph.D. preferred).
- Experience:At least 6 years of experience as a biostatistician, ideally in the CRO industry or a related clinical research field.
- Leadership:Proven ability to effectively lead and mentor technical teams within a multidisciplinary environment, ensuring high-quality outputs and efficient project execution.
- Technical Expertise:Expert knowledge of statistical methods and techniques applicable to clinical trials, including proficiency in statistical software and programming languages (SAS, R, etc.).
- Regulatory Knowledge:In-depth understanding of GCP (Good Clinical Practice) guidelines, CDISC (Clinical Data Interchange Standards Consortium), and other regulatory requirements related to clinical trials.
- Communication Skills:Exceptional verbal and written communication skills, with the ability to engage with both technical and non-technical stakeholders, including clients and regulatory bodies.
- Problem-Solving:Strong analytical and problem-solving skills, with the ability to troubleshoot complex statistical issues and provide innovative solutions.
- Customer Service Focus:A strong commitment to high-quality customer service delivery, ensuring client satisfaction through timely and accurate statistical analysis and reporting.
STRAGO is an equal employment opportunity employer. If your application is among those most in line with the required profile, you will be contacted to continue the selection process.
