About the role
Job Description The Principal Biostatistician leads teams of biostatisticians and statistical programmers in creating unblinded reports of confidential, ongoing clinical trial data for DMCs. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.
Responsibilities RESPONSIBILITIES
- Implements a wide variety of statistical methodologies
- Presents statistical reports to DMCs and clients.
- Provides guidance and oversight of biostatistics and programming teams in production of statistical analyses and reports, including interim analyses and adaptations, for DMCs.
- Ensures blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related SOPs and regulatory requirements.
- Serves as primary contact for DMCs.
- Hosts DMC meetings and presents unblinded reports to the DMC in closed meeting sessions.
- Leads and facilitates project team meetings on a regular basis.
- Develops and facilitates internal and external presentations, as appropriate.
- Interact and coordinate with non-DMC Cytel functional groups.
Qualifications QUALIFICATIONS
- Master’s degree or PhD in Biostatistics, Statistics, or related field.
- With PhD, a minimum of 6 years of industry experience, with MS a minimum of 8 years of industry experience.
- Expert level knowledge of statistical concepts with working knowledge of medical/scientific terminology
- Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
- Prior unblinded DMC experience required.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
About the role
Job Description The Principal Biostatistician leads teams of biostatisticians and statistical programmers in creating unblinded reports of confidential, ongoing clinical trial data for DMCs. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.
Responsibilities RESPONSIBILITIES
- Implements a wide variety of statistical methodologies
- Presents statistical reports to DMCs and clients.
- Provides guidance and oversight of biostatistics and programming teams in production of statistical analyses and reports, including interim analyses and adaptations, for DMCs.
- Ensures blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related SOPs and regulatory requirements.
- Serves as primary contact for DMCs.
- Hosts DMC meetings and presents unblinded reports to the DMC in closed meeting sessions.
- Leads and facilitates project team meetings on a regular basis.
- Develops and facilitates internal and external presentations, as appropriate.
- Interact and coordinate with non-DMC Cytel functional groups.
Qualifications QUALIFICATIONS
- Master’s degree or PhD in Biostatistics, Statistics, or related field.
- With PhD, a minimum of 6 years of industry experience, with MS a minimum of 8 years of industry experience.
- Expert level knowledge of statistical concepts with working knowledge of medical/scientific terminology
- Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
- Prior unblinded DMC experience required.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.