Senior Biostatistician, Clinical Trial Experience Required
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Biostatistician leading clinical-trial design, programming, and statistical reporting for CTI, a global full-service clinical research CRO. Overseeing SDTM/ADaM analyses, regulatory submissions, and project delivery.
Responsibilities:
- Assist with development and modification of department SOPs and work instructions
- Train new Biostatistics employees and mentor junior Biostatisticians
- Develop study bids and scope changes for prospective client RFPs
- Present Biostatistics study execution tasks at capabilities presentations
- Serve as primary statistical contact for internal and external project team members
- Manage Biostatistics tasks within project timelines and communicate timeline changes
- Identify and communicate changes in scope
- Review case report forms and completion instructions
- Provide input on database design and data-edit considerations
- Develop or review Interim Analysis Plans and Statistical Analysis Plans
- Develop or review SDTM and ADaM dataset specifications and mock tables, listings, and figures
- Independently program derived datasets and TLFs and validate corresponding programs
- Review programming by other team members
- Develop or review statistical methods and results sections for reports, CSRs, and publications
- Plan and design clinical studies, including endpoints, power analysis, randomization, blinding, and protocol statistical methods
- Develop or review Randomization Plans and randomization programs or lists
- Perform activities according to CTI SOPs, project conventions, GCP, and ICH guidelines
- Maintain accurate work records and file statistics documents in the eTMF
- Participate in departmental meetings
Requirements:
- At least 4 years of related biostatistics experience in a pharmaceutical, CRO, or related statistical environment
- Master’s degree in Biostatistics, Statistics, or a related field
- CDISC, SDTM, and ADaM dataset mapping experience
- BLA/NDA submission experience preferred
- Regulatory representation experience preferred, including meeting preparation/attendance and regulatory communication follow-up
- Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology, and rare disease preferred
- Experience providing statistical consulting to internal/external clients preferred
- Ability to work within Good Clinical Practice and International Conference on Harmonization guidelines
- Knowledge of biostatistics SOPs and project-specific conventions
- Ability to independently program derived datasets and TLFs and validate programs
- Experience with Interim Analysis Plans, Statistical Analysis Plans, Randomization Plans, SDTM, ADaM, and clinical study reports
Benefits:
- Structured mentoring program
- Leadership courses
- Tuition reimbursement
- Ongoing education and training
- Dedicated training department
- Award-winning company culture
- Work-life balance support
- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- CTI Cares program
- Career progression support
Similar Jobs
Clinical Research Associate II
Clinical Research Associate II monitoring diagnostic clinical studies for Karius, a genomic infectious-disease diagnostics company. Managing investigative sites, data verification, compliance, and monitoring visits.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and research organization. Ensuring protocol compliance, data integrity, site performance, and regulatory standards.
Head of Clinical Research
Head of Clinical Research leading grants, publications, and research governance for CSD’s autism and developmental-services network. Advancing evidence-based ABA, telehealth, and technology-enabled care.
Clinical Research Associate II
Clinical Research Associate II advancing AbbVie’s innovative medicines through clinical trial site management. Monitoring sites, ensuring compliance, data integrity, recruitment, and patient safety.
Clinical Research Associate, U.S. Expert Network
Clinical Research Associate joining Alcedis, a Germany-based clinical research organization expanding in the United States. Supporting oncology and Alzheimer’s clinical trials through flexible, project-based monitoring assignments.
Senior Clinical Research Associate
Senior Clinical Research Associate advancing AbbVie’s innovative medicines through site monitoring and clinical trial execution. Partnering with investigators and study teams to ensure compliance, patient safety, data integrity, and recruitment success.
Senior Manager, Clinical Trial Management
Senior clinical trial manager overseeing pharmaceutical and device studies for Precision Medicine Group. Leading feasibility, monitoring, compliance, recruitment, vendors, and clinical teams remotely in the United States.
Senior Biostatistician
Senior Biostatistician leading observational studies using real-world clinico-genomic cancer data for AACR Project GENIE. Designing analyses, programming in R, and translating findings into publications.
Principal Biostatistician
Principal Biostatistician leading statistical strategy, analyses, and regulatory delivery for Fortrea’s global clinical-trial programs. Mentoring statisticians and advising multidisciplinary teams across complex CRO studies.
Clinical Research Manager
Clinical Research Manager overseeing ophthalmology trials for TFS HealthScience, a global contract research organization. Coordinating CRAs, sites, sponsors, monitoring quality, and study delivery across Poland, Spain, and Italy.
Clinical Research Lead
Site Engagement Liaison building clinical trial site relationships for ICON, a global healthcare intelligence and clinical research organisation. Supporting study compliance, engagement strategies, and site performance.
Senior Clinical Research Associate
Senior Clinical Research Associate managing oncology and complex clinical trials for ClinChoice, a global full-service CRO. Conducting site monitoring, data verification, safety reporting and study closeout.
Senior Clinical Research Associate
Senior Clinical Research Associate overseeing oncology Phase I trials for ICON, a global clinical research organisation. Managing investigative sites, monitoring data integrity, and ensuring patient safety and inspection readiness.
In-House Clinical Research Associate II
In-house Clinical Research Associate supporting site management and data-quality activities for Worldwide Clinical Trials, a global contract research organization. Coordinating clinical-study documentation, monitoring support, queries, recruitment, and site communications.
Senior Clinical Research Associate – CNS
Senior Clinical Research Associate managing CNS clinical trial sites for Worldwide Clinical Trials, a global CRO. Overseeing study start-up, site maintenance, compliance, and closeout activities.
Clinical Research Associate 2
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organisation. Ensuring protocol compliance, data integrity, patient safety, and high-quality study delivery.
Senior Clinical Research Associate – Oncology
Senior Clinical Research Associate monitoring oncology trials for ICON, a global clinical research organisation. Conducting site visits, ensuring compliance, and overseeing patient safety, data quality, and site performance.
Clinical Research Associate – Oncology
Clinical Research Associate monitoring oncology and hematology trials for ICON, a global clinical research organization. Conducting site visits, ensuring compliance, and supporting patient safety and data quality.
Local Clinical Trial Manager – Single Sponsor
Clinical Trial Manager responsible for site management and monitoring in drug development at Syneos Health. Ensuring compliance and data integrity for clinical trial deliverables.
Senior Clinical Trial Manager
Senior Clinical Trial Manager overseeing and coordinating clinical trials at Sitero, ensuring compliance and project milestone achievements.