Senior Biostatistics Director
1 week ago
We are a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
Job SummaryWe are seeking a highly skilled and customer-focused individual to join our team as Associate Director, Biostatistics (Statistical Operations) for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada.
Key Responsibilities- Manage clinical trial programs/projects from one or multiple clients, working with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics.
- Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
- Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers.
- Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
- Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
- Provide statistical input in protocol design and development, participate in the writing of trial protocols and research proposals.
- Review and provide input to clinical data management deliverables, including electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
- Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs).
- Perform peer review of SAPs and other technical documents written by others.
- Perform hands-on statistical analysis and modeling, maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
- Validate core statistical tables, listings, and figures programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate.
- Perform overall quality control (QC) review on statistical deliverables before they are released to the clients.
- Review and confirm ADaM dataset specifications, perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
- Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.
- Act as a consultant to less experienced Biostatisticians.
- Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
- Interact with regulatory agencies and support Sponsor in new drug application, participating as a statistical liaison to the regulatory agency on behalf of the Sponsor company.
- Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
- Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
- Assist in business development activities, including providing cost estimates of statistical and programming services, participating in generation of project proposals and bid defense meetings, and participating in professional trade shows when required.
- Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.
- Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.
- A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience.
- Demonstrated exceptional ability and performance.
-
Senior Biostatistics Director
2 weeks ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout Everest Clinical Research Services IncEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.We serve some of the best-known companies and work with many of the most advanced...
-
Senior Biostatistics Director
2 weeks ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout Everest Clinical Research Services IncEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.We serve some of the best-known companies and work with many of the most advanced...
-
Senior Biostatistics Director
4 days ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide.About UsWe have a strong foundation as a statistical and data management center of excellence,...
-
Senior Biostatistics Director
4 days ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide.About UsWe have a strong foundation as a statistical and data management center of excellence,...
-
Senior Biostatistics Director
2 weeks ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout Everest Clinical Research Services IncEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our company has a strong foundation as a statistical and data management center of...
-
Senior Biostatistics Director
2 weeks ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout Everest Clinical Research Services IncEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our company has a strong foundation as a statistical and data management center of...
-
Associate Director, Biostatistics Lead
10 hours ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership, and ensuring the delivery...
-
Associate Director, Biostatistics Lead
13 hours ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership, and ensuring the delivery...
-
Associate Director, Biostatistics Lead
2 days ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership to project teams, and...
-
Associate Director, Biostatistics Lead
1 day ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership to project teams, and...
-
Senior Biostatistician
1 day ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeSenior Biostatistician Job DescriptionEverest Clinical Research Services Inc is seeking a highly skilled Senior Biostatistician to join our team in Markham, Ontario or remotely from a home-based office in Canada.Key Responsibilities:Lead statistical planning and methodologies for clinical trials and research projects.Develop and review statistical analysis...
-
Senior Biostatistician
2 days ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeSenior Biostatistician Job DescriptionEverest Clinical Research Services Inc is seeking a highly skilled Senior Biostatistician to join our team in Markham, Ontario or remotely from a home-based office in Canada.Key Responsibilities:Lead statistical planning and methodologies for clinical trials and research projects.Develop and review statistical analysis...
-
Nurse Practitioner
1 day ago
Markham, Ontario, Canada Sunrise Senior Living Full timeJob Title: Nurse Practitioner - Senior CareAt Sunrise Senior Living, we are passionate about providing high-quality care to our residents. We are seeking a skilled and compassionate Nurse Practitioner to join our team.Responsibilities:Conduct regular wellness visits for all residents to identify and address any health concerns.Collaborate with the Resident...
-
Nurse Practitioner
1 day ago
Markham, Ontario, Canada Sunrise Senior Living Full timeJob Title: Nurse Practitioner - Senior CareAt Sunrise Senior Living, we are passionate about providing high-quality care to our residents. We are seeking a skilled and compassionate Nurse Practitioner to join our team.Responsibilities:Conduct regular wellness visits for all residents to identify and address any health concerns.Collaborate with the Resident...
-
Senior Care Professional
1 day ago
Markham, Ontario, Canada Sienna Senior Living Full timeAbout the RoleWe are seeking a highly skilled and dedicated Clinical Care Partner to join our team at Sienna Senior Living. As a Clinical Care Partner, you will play a vital role in ensuring the highest quality of care and services for our residents.Key ResponsibilitiesCollaborate with regional leaders to provide support and guidance to care community team...
-
Senior Care Professional
1 day ago
Markham, Ontario, Canada Sienna Senior Living Full timeAbout the RoleWe are seeking a highly skilled and dedicated Clinical Care Partner to join our team at Sienna Senior Living. As a Clinical Care Partner, you will play a vital role in ensuring the highest quality of care and services for our residents.Key ResponsibilitiesCollaborate with regional leaders to provide support and guidance to care community team...
-
Training Partner
2 days ago
Markham, Ontario, Canada Sienna Senior Living Full timeAbout Sienna Senior LivingWe are a leading owner and operator of seniors' residences in Canada, committed to providing care, support, services, and housing to seniors and their families.Job SummaryWe are seeking a skilled Clinical Care Partner to join our team. As a Clinical Care Partner, you will play a key role in ensuring that care meets and/or exceeds...
-
Training Partner
2 days ago
Markham, Ontario, Canada Sienna Senior Living Full timeAbout Sienna Senior LivingWe are a leading owner and operator of seniors' residences in Canada, committed to providing care, support, services, and housing to seniors and their families.Job SummaryWe are seeking a skilled Clinical Care Partner to join our team. As a Clinical Care Partner, you will play a key role in ensuring that care meets and/or exceeds...
-
Senior RAMS Director
1 week ago
Markham, Ontario, Canada Parsons Corporation Full timeSystem Safety and RAM DirectorWe are seeking a highly experienced System Safety and RAM Director to lead our Critical Infrastructure team in Canada.Key Responsibilities:Support Transit Authorities and suppliers in the review and assessment of Systems Assurance procurement or development documentation.Deliver RAMS procurement or development documentation and...
-
Senior RAMS Director
1 week ago
Markham, Ontario, Canada Parsons Corporation Full timeSystem Safety and RAM DirectorWe are seeking a highly experienced System Safety and RAM Director to lead our Critical Infrastructure team in Canada.Key Responsibilities:Support Transit Authorities and suppliers in the review and assessment of Systems Assurance procurement or development documentation.Deliver RAMS procurement or development documentation and...
