A Senior Biostatistician dedicated to a global pharmaceutical client, supporting Phase I-IV clinical studies from design through to regulatory submissions.
Responsibilities
Providing statistical support to clinical studies
Participating in the development of study protocols, including participation in study design discussions and sample size calculations
Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
Performing statistical analyses and interpreting statistical results
Preparing clinical study reports, including integrated summaries for submissions
Requirements
Bachelor's degree in statistics or a related discipline
A Global Clinical Program Lead accountable for a significant proportion of the clinical program, usually an indication-aligned cluster of clinical studies, supervising a team of Global Development Medical Directors and Scientist Directors.
Compensation
The annual base salary for this position ranges from $288,059 - $432,088.
Responsibilities
Supervise a team of Global Development Medical Directors and/or Global Development Scientist Directors
Work cross functionally to support the design, conduct, monitoring and data interpretation of multiple studies
Ensure clinical data collected allows for determination of benefits and risks of the compound and meets label indication and price
Set vision and goals against therapeutic area leadership priorities and product strategy
Ensure timely decision making and facilitate the balance of cost/time/quality against clinical development objectives
The Executive Medical Director (EMD) leads multiple clinical development programs, provides medical leadership, oversees regulatory strategy, and represents the organization in global meetings.
Compensation
The annual base pay for this position ranges from 331,873.60 to 497,810.40 USD Annual . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Lead and oversee 2 or more clinical development programs
Provide medical oversight and mentorship to Medical Directors and Clinical Development Scientists
Serve on cross-asset strategic teams and contribute to strategic decisions
Develop regulatory strategy and therapeutic area plans
Act as medical monitor for clinical trials
Requirements
M.D. or equivalent
Ph.D. in related discipline (desirable)
Nice to have: advanced knowledge of assigned therapy area
Nice to have: 7+ years industry experience in clinical development
Lead commissioning and validation activities for bio-pharmaceutical and regulated facilities across North America, ensuring compliance with design and regulatory requirements.
Responsibilities
Perform commissioning/validation tasks including reviewing shop drawings and equipment submittals
Generate commissioning and validation plans, user requirement specifications, functional and design specifications
Prepare commissioning/validation protocols adhering to specifications and client templates
Assist in execution of commissioning/validation project protocols, including discrepancies and final reports
Assist Director of Commissioning/Validation with client presentations and communication
Requirements
Bachelor's Degree in Engineering with emphasis in Mechanical, Electrical or Chemical Engineering
Provide scientific leadership for clinical research programs supporting product development, regulatory approvals, post-market evidence generation, and scientific communication activities.
Compensation
The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted.
Responsibilities
Lead scientific activities associated with the design, execution, analysis, interpretation, and reporting of clinical studies.
Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
Lead scientific activities for clinical research programs supporting product development, regulatory approvals, post‑market evidence generation, and scientific communication.
Compensation
The base pay for this position is $78,000.00 – $156,000.00
Responsibilities
Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
Design prospective clinical studies, registries, observational studies, post‑market studies, and evidence‑generation programs supporting global regulatory and business objectives.
Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
Develop scientific rationale supporting study design, endpoint selection, evidence‑generation strategies, and clinical development plans.
Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
Requirements
Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
Lead scientific activities for clinical research programs supporting product development, regulatory approvals, and evidence generation in the Electrophysiology division.
Compensation
$78,000.00 – $156,000.00
Responsibilities
Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
Design prospective clinical studies, registries, observational studies, post‑market studies, and evidence‑generation programs supporting global regulatory and business objectives.
Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
Develop scientific rationale supporting study design, endpoint selection, evidence‑generation strategies, and clinical development plans.
Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
Requirements
Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
Global Study Manager/Lead responsible for end-to-end clinical study delivery, budgeting, risk management, and stakeholder communication across multiple regions.
Responsibilities
Accountable for operational delivery of clinical studies to time, quality, and budget
Generate robust delivery plans and deliver to target thresholds
Lead study team and matrix teams
Develop protocol and informed consent documents
Conduct investigator meetings and other study related meetings
Requirements
Bachelor’s degree in life sciences or related discipline
Provide statistical expertise for clinical trials, support study design, execution, analysis, and reporting, and collaborate with cross‑functional teams.
Compensation
$133,000.00-173,000.00 Annual
Responsibilities
Provide statistical input into protocol development, statistical analysis plans, and other key trial documents
Support study setup activities including randomization, sample size justification, and selection of appropriate analysis methods
Perform or oversee statistical analyses of clinical trial data to ensure timely and accurate reporting
Contribute to the preparation of clinical study reports, regulatory submissions, and responses to health authority queries
Collaborate with cross‑functional teams (clinical, programming, data management, regulatory) to ensure statistical integrity and compliance
Senior Biostatistician (FSP + Remote)NewCytel Inc · Remote, United Kingdom
Senior Commissioning/Validation SpecialistNewStantec · Cleveland, US