Senior Biostatistician FSP
1 week ago
Senior Biostatistician – Phase I‑IV Clinical Development Job Description We are seeking an experienced Biostatistician with a passion for clinical development and advanced statistical methods. The successful candidate will support or lead one or more Phase I‑IV clinical studies, working embedded within a global pharmaceutical client and supported by Cytel. The role focuses on clinical trial design, analysis, and regulatory submissions. Responsibilities Providing statistical support to clinical studies Participating in development of study protocols, study design discussions and sample size calculations Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including dataset and TLG specifications Performing statistical analyses and interpreting results Preparing clinical study reports and integrated summaries for submissions Communicating methodology and decisions to internal and external stakeholders Ensuring compliance with ICH, Good Clinical Practice and electronic submission guidelines Driving and supporting publication‑related activities and adhoc requests Contributing to creation, maintenance, documentation and validation of programming tools, outputs and macros Reviewing CRFs, edit check specifications and data validation plans Providing review or authoring data transfer specifications for external vendor data Collaborating with CROs, software vendors, clinical partners to meet project timelines and goals Reviewing or authoring SOPs or work instructions related to statistical programming practices Qualifications Master’s degree in statistics or related discipline; Ph.D. preferred 5+ years of supporting clinical trials in the pharmaceutical or biotechnology industry Experience working for a CRO strongly desired Experience with sample size calculation, protocol development, SAP, and preparing clinical study reports, including integrated summaries and safety reporting Strong SAS programming skills for QCing outputs, efficacy/safety tables, and collaboration with programmers; knowledge of R desirable Solid understanding of CDISC requirements for regulatory submissions Experience generating and QCing ADaM specifications Ability to build strong external and internal relationships and motivate team Effective communication skills, able to explain methodology in lay terms Seniority Level Not Applicable Employment Type Full‑time Job Function Research, Analyst, and Information Technology Industry Pharmaceutical Manufacturing #J-18808-Ljbffr
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Principal Biostatistician
7 days ago
Canada Cytel, Inc (USA) Full timeCytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...
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Principal Statistician
6 days ago
, , Canada Warman O'Brien Full timeOverview Principal Biostatistics Consultant @ Warman O'Brien Limited | Recruiting Statisticians Principal Biostatistician – Real-World Evidence (RWE) – Global CRO – FSP Model Are you an experienced Biostatistician with a passion for Real-World Evidence (RWE) and Real-World Data (RWD) ? Join a global, high-performance team where your statistical...
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, , Canada Cytel Full timeA global pharmaceutical services company is seeking a Senior Biostatistician to support or lead Phase I‑IV clinical studies. The role requires expertise in statistical analysis and clinical trial design, including responsibilities such as preparing clinical study reports, ensuring compliance with regulations, and collaborating with various partners....
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Clinical Data Management Senior Manager
1 week ago
Canada Warman O'Brien Full timeSenior Lead Clinical Data Manager | CRO - FSP | Remote – Canada | Permanent | Are you ready to take your Clinical Data Management expertise to the next level? Join us as a Senior Lead Clinical Data Manager and play a pivotal role in driving data strategy, innovation, and excellence across global clinical programs. This fully remote position offers the...
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Clinical Data Management Senior Manager
1 week ago
Canada Warman O'Brien Full timeSenior Lead Clinical Data Manager | CRO - FSP | Remote – Canada | Permanent | Are you ready to take your Clinical Data Management expertise to the next level? Join us as a Senior Lead Clinical Data Manager and play a pivotal role in driving data strategy, innovation, and excellence across global clinical programs. This fully remote position offers the...
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Clinical Data Management Senior Manager
1 week ago
Canada Warman O'Brien Full timeSenior Lead Clinical Data Manager | CRO - FSP | Remote – Canada | Permanent | Are you ready to take your Clinical Data Management expertise to the next level? Join us as a Senior Lead Clinical Data Manager and play a pivotal role in driving data strategy, innovation, and excellence across global clinical programs. This fully remote position offers the...
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Clinical Data Management Senior Manager
2 weeks ago
Canada Warman O'Brien Full timeSenior Lead Clinical Data Manager | CRO - FSP | Remote – Canada | Permanent | Are you ready to take your Clinical Data Management expertise to the next level? Join us as a Senior Lead Clinical Data Manager and play a pivotal role in driving data strategy, innovation, and excellence across global clinical programs. This fully remote position offers the...
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Senior Biostatistician
1 week ago
, , Canada ProPharma Group Full timeOther duties as assigned. **Necessary Skills and Abilities:**In-depth knowledge of statistical methodologies. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners. Strong project management skills, with the ability to manage multiple projects simultaneously. Knowledge...
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Clinical Data Manager
1 week ago
Canada Warman O'Brien Full timeSenior Lead Clinical Data Manager | Remote – Canada | Leading CRO - FSP | Are you an experienced Clinical Data Manager looking to step into a leadership role with global impact? We’re seeking a Lead / Senior Lead Clinical Data Manager to oversee the end-to-end delivery of Data Management (DM) services for complex clinical studies and programs. This is a...
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Senior Clinical Data Manager
3 weeks ago
Canada Warman O'Brien Full timeSenior Lead Clinical Data Manager | CRO - FSP | Remote – Canada | Permanent | Are you ready to take your Clinical Data Management expertise to the next level? Join us as a Senior Lead Clinical Data Manager and play a pivotal role in driving data strategy, innovation, and excellence across global clinical programs. This fully remote position offers the...
