About the role
Principal Biostatistician – Vaccines Therapeutic Area
We are seeking a highly skilled FSP Statistician to support projects in the Vaccines Therapeutic Area within Research and Development. The successful candidate will collaborate closely with project and study teams, providing statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, reviewing reports, and co-authoring manuscripts for publication. This role may also involve supporting regulatory submissions and responding to regulatory queries. Ideal candidates will demonstrate strong quantitative and creative thinking and stay current with developments in statistical methodologies.
Responsibilities & Duties
- Provide scientifically rigorous statistical input on post-hoc and ad-hoc analysis requests to support publication projects and regulatory query responses.
- Develop statistical analysis plans, mock-up tables, and quality check plans.
- Oversee programming support activities for assigned projects and validate the accuracy, consistency, and integrity of statistical output displays generated by programmers.
- Lead multiple project teams using project management skills and statistical/programming techniques to prepare, execute, report, and document high-quality statistical analyses.
- Conduct peer reviews of project-related work performed by other statisticians, ensure compliance with regulatory requirements, and maintain project documentation and files.
- Communicate effectively and independently with the client to coordinate statistical and programming aspects of the project.
- Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.
Basic Qualifications
- Master’s degree in Statistics/Biostatistics with 8+ years of experience in clinical trials, or PhD in Statistics/Biostatistics with 4+ years of experience.
- Effective verbal and written communication skills.
- Understanding of broad statistical theory and its application.
- Ability to understand clinical questions and concepts and translate them into SAP development, followed by data generation and publication.
- Ability to clearly explain statistical concepts to colleagues without statistical training.
- Strong team collaboration skills.
- Experience with statistical modeling of clinical data and statistical inference.
- Proficiency in R or SAS programming languages.
- Located in a time zone within the United States or Europe (UTC-8 to UTC+2) to support real-time collaboration.
Preferred Qualifications
- Strong computational skills.
- Experience with various study designs, protocol development, and statistical analysis plan writing.
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming.
We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
About the role
Principal Biostatistician – Vaccines Therapeutic Area
We are seeking a highly skilled FSP Statistician to support projects in the Vaccines Therapeutic Area within Research and Development. The successful candidate will collaborate closely with project and study teams, providing statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, reviewing reports, and co-authoring manuscripts for publication. This role may also involve supporting regulatory submissions and responding to regulatory queries. Ideal candidates will demonstrate strong quantitative and creative thinking and stay current with developments in statistical methodologies.
Responsibilities & Duties
- Provide scientifically rigorous statistical input on post-hoc and ad-hoc analysis requests to support publication projects and regulatory query responses.
- Develop statistical analysis plans, mock-up tables, and quality check plans.
- Oversee programming support activities for assigned projects and validate the accuracy, consistency, and integrity of statistical output displays generated by programmers.
- Lead multiple project teams using project management skills and statistical/programming techniques to prepare, execute, report, and document high-quality statistical analyses.
- Conduct peer reviews of project-related work performed by other statisticians, ensure compliance with regulatory requirements, and maintain project documentation and files.
- Communicate effectively and independently with the client to coordinate statistical and programming aspects of the project.
- Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.
Basic Qualifications
- Master’s degree in Statistics/Biostatistics with 8+ years of experience in clinical trials, or PhD in Statistics/Biostatistics with 4+ years of experience.
- Effective verbal and written communication skills.
- Understanding of broad statistical theory and its application.
- Ability to understand clinical questions and concepts and translate them into SAP development, followed by data generation and publication.
- Ability to clearly explain statistical concepts to colleagues without statistical training.
- Strong team collaboration skills.
- Experience with statistical modeling of clinical data and statistical inference.
- Proficiency in R or SAS programming languages.
- Located in a time zone within the United States or Europe (UTC-8 to UTC+2) to support real-time collaboration.
Preferred Qualifications
- Strong computational skills.
- Experience with various study designs, protocol development, and statistical analysis plan writing.
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming.
We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.