Statistician – Biosimilar Phase I Studies K3-Innovations is seeking a Statistician to lead the design and analysis of biosimilar clinical trials , focusing on Phase I trials including PK/PD equivalence , Bayesian methods , and regulatory strategy . Key Responsibilities: Design and analyze biosimilar Phase I trials (PK/PD, immunogenicity) Apply Bayesian modeling and adaptive design strategies Author SAPs, protocols, and study reports Develop Cutting Edg Trial Designs Present statistical designs and results to the FDA and other agencies 25% Travel to US Qualifications: Master’s/Ph.D. in Biostatistics or related field 8+ years in clinical trial statistics, including 5+ in biosimilars Expertise in Bayesian methods and equivalence study design Experience presenting at FDA meetings (e.g., Type B, Scientific Advice) Proficiency in R, SAS, Stan, JAGS, or WinBUGS Knowledge of FDA/EMA biosimilar and ICH guidance Show more Show less
Statistician – Biosimilar Phase I Studies NY Metro Area (hybrid) K3-Innovations is seeking a Statistician to lead the design and analysis of biosimilar clinical trials , focusing on Phase I trials including PK/PD equivalence , Bayesian methods , and regulatory strategy . Key Responsibilities: Design and analyze biosimilar Phase I trials (PK/PD, immunogenicity) Apply Bayesian modeling and adaptive design strategies Author SAPs, protocols, and study reports Develop Cutting Edge Trial Designs Present statistical designs and results to the FDA and other agencies Qualifications: Master’s/Ph.D. in Biostatistics or related field 8+ years in clinical trial statistics, including 5+ in biosimilars Expertise in Bayesian methods and equivalence study design Experience presenting at FDA meetings (e.g., Type B, Scientific Advice) Proficiency in R, SAS, Stan, JAGS, or WinBUGS Knowledge of FDA/EMA biosimilar and ICH guidance Show more Show less
Job Title - Medidata RAVE - System Designer Location - Remote Role and Responsibility- Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP). Provide subject matter expertise to project team members during all phases of project life cycle. Develop, test, and maintain data management systems. Provide subject matter expertise prior, during and post internal and external audits and inspections. Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data). Batch import agreed data sources into the EDC system. Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards. Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules. Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries. Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer). Conduct, test, and produce Rave EDC Migration activities as required. Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications. Coordinate and manage the deployment of new or modified EDC databases into production. Assist in mapping the EDC database to the company enterprise data warehouse. As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build proc Be available to work on any studies Work according to SOPs/WI
Commitment: Full-Time Contract (30–40 hours per week) Location: Based in India, Remote – Eastern Time Zone (preferred) or Mountain Time Zone Reports To: Clinical QA Lead / Director of Quality Position Overview We are seeking an experienced QA Specialist / Manager-level contractor to provide day-to-day clinical quality assurance (QA) support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP) , and ensuring quality oversight. The ideal candidate brings strong experience with Veeva QMS , is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment. Key Responsibilities Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards. Provide QA expertise during study calls, including: Protocol deviation meetings Risk-based quality management discussions Study operations and trial oversight meetings Write, review, update, and format standard operating procedures (SOPs) and other quality documentation. Manage and track quality processes within Veeva QMS , including document control, training, and CAPA management. Address QA-related questions from study teams in real time, providing clear and actionable guidance. Support inspection readiness and contribute to continuous improvement of QA systems and processes. Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation. Qualifications Education: Bachelor’s degree in life sciences, healthcare, or related discipline (advanced degree preferred). Experience: 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP. Prior experience supporting clinical study teams in a QA capacity. Hands-on experience with Veeva QMS . Technical Skills: Proficient in MS Office (Excel, PowerPoint, Word). Skilled in technical writing, SOP drafting, and document formatting. Soft Skills: Excellent communication and interpersonal skills. Strong organizational skills with the ability to work independently. Availability: Must be available during Eastern or Mountain Time Zone working hours to attend study calls and provide timely QA support. Contract Opportunity This is a full-time contract role offering 30–40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.
Commitment: Full-Time Contract (3040 hours per week) Location: Based in India, Remote Eastern Time Zone (preferred) or Mountain Time Zone Reports To: Clinical QA Lead / Director of Quality Position Overview We are seeking an experienced QA Specialist / Manager-level contractor to provide day-to-day clinical quality assurance (QA) support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP) , and ensuring quality oversight. The ideal candidate brings strong experience with Veeva QMS , is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment. Key Responsibilities Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards. Provide QA expertise during study calls, including: Protocol deviation meetings Risk-based quality management discussions Study operations and trial oversight meetings Write, review, update, and format standard operating procedures (SOPs) and other quality documentation. Manage and track quality processes within Veeva QMS , including document control, training, and CAPA management. Address QA-related questions from study teams in real time, providing clear and actionable guidance. Support inspection readiness and contribute to continuous improvement of QA systems and processes. Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation. Qualifications Education: Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred). Experience: 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP. Prior experience supporting clinical study teams in a QA capacity. Hands-on experience with Veeva QMS . Technical Skills: Proficient in MS Office (Excel, PowerPoint, Word). Skilled in technical writing, SOP drafting, and document formatting. Soft Skills: Excellent communication and interpersonal skills. Strong organizational skills with the ability to work independently. Availability: Must be available during Eastern or Mountain Time Zone working hours to attend study calls and provide timely QA support. Contract Opportunity This is a full-time contract role offering 3040 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.