Responsibilities
- Design and implement statistical analysis plans for oncology clinical trials.
- Collaborate with cross-functional teams to develop study protocols and statistical sections of clinical study reports.
- Perform complex statistical analyses and interpret results to support clinical trial objectives.
- Prepare and review regulatory submissions, including statistical sections of INDs, NDAs, and BLA.
- Provide statistical expertise and guidance to internal and external stakeholders, including clinical trial investigators and sponsors.
- Develop and maintain statistical standard operating procedures and guidelines.
- Contribute to the development of statistical software and tools to enhance data analysis and reporting capabilities.
- Stay current with industry trends, regulatory requirements, and statistical methodologies relevant to oncology clinical trials.
- Mentor and train junior biostatisticians and statistical programmers.
- Ensure the quality and integrity of statistical analyses and reporting through peer review and quality control processes.
- Participate in the preparation of manuscripts and presentations for scientific conferences and publications.
- Collaborate with data management and programming teams to ensure accurate and timely data collection, management, and analysis.
- Provide input on the design and implementation of clinical trial databases and data collection tools.
- Assist in the development and implementation of risk-based monitoring strategies to enhance data quality and trial efficiency.
- Contribute to the development and implementation of adaptive trial designs and innovative statistical methodologies.
- Participate in the review and approval of clinical trial protocols, informed consent forms, and other study-related documents.
- Provide statistical support to internal and external audits and inspections.
- Collaborate with medical writers to ensure accurate and clear presentation of statistical results in clinical study reports and other documents.
- Participate in the development and implementation of statistical training programs for internal and external stakeholders.
- Contribute to the development and implementation of statistical standards and best practices for clinical trial conduct and reporting.
- Provide statistical support to the development and implementation of real-world evidence studies and other post-marketing research initiatives.
- Collaborate with other departments to ensure the integration of statistical considerations into the overall clinical development strategy.
- Participate in the development and implementation of statistical methods for the analysis of complex and high-dimensional data sets.
Nice to Have
- Experience with oncology clinical trials, including Phase I to Phase IV studies.
- Familiarity with oncology-specific statistical methodologies and regulatory requirements.
- Experience with adaptive trial designs and innovative statistical methodologies.
- Knowledge of industry trends and best practices in biostatistics and clinical trial design.
- Experience with risk-based monitoring and other strategies to enhance data quality and trial efficiency.
- Ability to develop and maintain statistical standard operating procedures and guidelines.
- Experience with the development and implementation of statistical software and tools.
- Ability to mentor and train junior biostatisticians and statistical programmers.
- Experience with the preparation of manuscripts and presentations for scientific conferences and publications.
- Knowledge of clinical trial databases and data collection tools.
- Experience with real-world evidence studies and other post-marketing research initiatives.
- Ability to provide statistical support to internal and external audits and inspections.
- Experience with the development and implementation of statistical training programs.
- Knowledge of statistical standards and best practices for clinical trial conduct and reporting.
- Ability to integrate statistical considerations into the overall clinical development strategy.
- Experience with the analysis of complex and high-dimensional data sets.
Compensation
Competitive salary and benefits package
Work Arrangement
On-site
Team
Collaborative and dynamic team environment
About Us
- We are a leading provider of biostatistical consulting services to the pharmaceutical and biotechnology industries.
- Our team of experienced biostatisticians works closely with our clients to design and implement innovative statistical solutions for clinical trials.
- We specialize in oncology clinical trials, with a focus on study design, data analysis, and regulatory submissions.
- Our mission is to deliver high-quality, statistically sound solutions that support the development of safe and effective therapies for patients.
- We are committed to staying current with industry trends, regulatory requirements, and statistical methodologies to ensure the success of our clients' clinical trials.
- Our team is dedicated to providing exceptional service and support to our clients, from study design to regulatory submission and beyond.
- We offer a collaborative and dynamic work environment, with opportunities for professional growth and development.
- Our team is comprised of experienced biostatisticians, statistical programmers, and other professionals with expertise in clinical trial design and analysis.
- We are committed to maintaining the highest standards of quality and integrity in all aspects of our work.
- Our team is dedicated to delivering innovative and effective statistical solutions that meet the unique needs of our clients and their clinical trials.
Our Culture
- We foster a culture of collaboration, innovation, and continuous learning.
- Our team values open communication, respect, and mutual support.
- We encourage professional development and provide opportunities for growth and advancement.
- Our work environment is dynamic and fast-paced, with a focus on delivering high-quality results.
- We are committed to maintaining a positive and inclusive work environment for all team members.
- Our team is dedicated to supporting each other and working together to achieve our shared goals.
- We value diversity and inclusion, and strive to create an environment where everyone feels valued and respected.
- Our team is committed to delivering exceptional service and support to our clients, and to maintaining the highest standards of quality and integrity in all aspects of our work.
- We encourage creativity and innovation, and provide opportunities for team members to contribute to the development of new ideas and solutions.
- Our team is dedicated to staying current with industry trends, regulatory requirements, and statistical methodologies to ensure the success of our clients' clinical trials.
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