RCS - RamAayanaM Clinical Solution - India, USA & Europe
RCS - RamAayanaM Clinical Solution is a global Contract Research Organization (CRO) providing comprehensive clinical research services from preclinical trials to Phase I-IV clinical trials. The company supports pharmaceutical, biopharmaceutical, nutraceutical, and medical device sectors with end-to-end clinical project management, regulatory affairs, clinical operations, data management, biostatistics, medical writing, pharmacovigilance, and quality assurance services. RCS differentiates itself through its worldwide site network, diverse therapeutic expertise, AI-powered in-house systems, and a strong foundation of scientific excellence. It operates globally with offices in India, USA, Portugal, and Spain, serving clients with a patient-centric approach and transparent project monitoring. The company emphasizes cost-effective, quality-driven solutions and has a large network of experienced clinical trial sites and investigators across multiple therapeutic areas.
AI IntegrationBiopharmaceuticalsClinical TrialsContract Research OrganizationMedical DevicesNutraceuticalsPharmaceuticalsRegulatory Affairsrclinicalsolution.com
RCS - RamAayanaM Clinical Solution - India, USA & Europe
RCS - RamAayanaM Clinical Solution is a global Contract Research Organization (CRO) providing comprehensive clinical research services from preclinical trials to Phase I-IV clinical trials. The company supports pharmaceutical, biopharmaceutical, nutraceutical, and medical device sectors with end-to-end clinical project management, regulatory affairs, clinical operations, data management, biostatistics, medical writing, pharmacovigilance, and quality assurance services. RCS differentiates itself through its worldwide site network, diverse therapeutic expertise, AI-powered in-house systems, and a strong foundation of scientific excellence. It operates globally with offices in India, USA, Portugal, and Spain, serving clients with a patient-centric approach and transparent project monitoring. The company emphasizes cost-effective, quality-driven solutions and has a large network of experienced clinical trial sites and investigators across multiple therapeutic areas.
AI IntegrationBiopharmaceuticalsClinical TrialsContract Research OrganizationMedical DevicesNutraceuticalsPharmaceuticalsRegulatory Affairsrclinicalsolution.com
Experience:
5 or more than 5 years relevant experience
Joining:
Immediate to 15 days
Compensation:
Best in industry
Specific Responsibilities:
Specific Authorities:
Job Specification:
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Collaborate with study teams to design clinical trials, including sample size calculation, randomization schemes, and statistical analysis plans.
Develop statistical analysis plans (SAPs) and oversee the implementation of statistical analyses.
Conduct statistical analyses of clinical trial data using appropriate methods, ensuring accuracy and reliability of results.
Interpret and present study findings to internal teams and external stakeholders, including regulatory agencies and clients.
Provide statistical input for protocol development, study reports, and local and global regulatory submissions.
Perform ad hoc analyses and exploratory data analyses as needed
Stay current with developments in biostatistics methodology and contribute to continuous improvement initiatives within the biostatistics team.
Develop and validate statistical analysis datasets (SDTM and ADaM) according to study protocols, statistical analysis plans (SAPs), and regulatory guidelines.
Program and validate tables, listings, and figures (TLFs) for clinical study reports (CSRs), integrated summaries of safety (ISS), and integrated summaries of efficacy (ISE) using SAS software.
Collaborate with biostatisticians, data managers, and other team members to ensure accurate and timely delivery of statistical programming deliverables.
Review and provide input on SAPs, case report forms (CRFs), and data validation specifications to ensure alignment with programming requirements.
Contribute to the development and maintenance of programming standards, templates, and macros to improve efficiency and consistency across projects.
Stay current with industry trends, regulatory guidance, and best practices in statistical programming, and contribute to continuous improvement initiatives within the programming team.
Ensure accuracy and completeness of datasets by conducting thorough programming and validation checks.
Create clear and informative graphical displays and statistical summaries to support data interpretation and decision-making.
Participate in team meetings and discussions to provide programming input, share insights on programming strategies, and contribute to decision-making processes.
Perform quality control (QC) checks on programming output, including datasets, TLFs, and other deliverables, to ensure accuracy, consistency, and compliance with company standards and regulatory requirements.
Address any discrepancies or issues identified during QC checks in a timely and effective manner, working collaboratively with team members to implement corrective actions as needed.
Maintain accurate and comprehensive documentation of programming activities, including programming specifications, validation plans, and QC documentation.
Statistical Analysis Implementation
Interpretation of Study Findings
Statistical Input for Study Protocols and Reports
Ad Hoc and Exploratory Analyses
Representing the Biostatistics Function
Collaboration and Communication
Programming and Validation of Statistical Analysis Datasets
Programming and Validation of Tables, Listings, and Figures (TLFs)
Collaboration with Study Teams
Quality Control (QC) Checks
Documentation and Standardization
Continued Professional Development
Programming and Validation of Statistical Analysis Datasets
Programming and Validation of Tables, Listings, and Figures (TLFs)
Collaboration with Cross-Functional Teams
Review and Input on Programming Specifications
Quality Control (QC) Checks
Development and Maintenance of Programming Standards
Minimum of 3-5 years of experience as Bisostatistics, SAS programmer, statistical programmer within the pharmaceutical or biotechnology industry, preferably in a CRO or clinical research setting.
Proficiency in SAS programming language, including experience with SAS/Base, SAS/STAT, SAS/GRAPH, and SAS Macro Language.
Strong understanding of CDISC standards (SDTM, ADaM) and familiarity with regulatory requirements (FDA, EMA, ICH) for clinical trial data submission.
Demonstrated experience in programming and validating statistical analysis datasets (SDTM and ADaM) and tables, listings, and figures (TLFs) for clinical trial reporting.
Proficiency in SAS programming language, including experience with SAS/Base, SAS/STAT, SAS/GRAPH, and SAS Macro Language.
Excellent problem-solving skills and attention to detail, with the ability to troubleshoot programming issues and implement effective solutions.
Effective communication skills, with the ability to collaborate effectively with cross-functional teams and communicate technical concepts to non-technical stakeholders.
Ability to work independently and manage multiple priorities in a fast-paced environment, while maintaining a high level of accuracy and quality in programming deliverables.
Experience with data manipulation, transformation, and statistical analysis using SAS software.
Ability to clearly document programming activities, including programming specifications, validation plans, and QC documentation
Familiarity with regulatory guidelines and standards related to statistical programming and clinical trial data reporting, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong proficiency in statistical software such as SAS or R
Experience with clinical trial design and analysis, preferably in a contract research organization or pharmaceutical industry setting
Solid understanding of statistical methods commonly used in clinical research, such as survival analysis, longitudinal data analysis, and Bayesian methods
Excellent communication skills, with the ability to effectively collaborate with multidisciplinary teams and present complex statistical concepts to non-statisticians
Detail-oriented with strong analytical and problem-solving skills
Excellent communication skills, with the ability to effectively collaborate with multidisciplinary teams and present complex statistical concepts to non-statisticians
Detail-oriented with strong analytical and problem-solving skills
Senior Biostatistician | RCS - RamAayanaM Clinical Solution - India, USA & Europe · Teeming.ai
