[Remote] Statistical Consultant
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company specializing in statistical consulting and clinical research. They are seeking a Statistical Consultant to reputed company and validate ADaM datasets, implement statistical analysis plans, and support statistical analyses for clinical studies and regulatory submissions.
Responsibilities
- reputed company and validate ADaM datasets based on approved specifications
- Implement Statistical Analysis Plans (SAPs) and programming specifications
- reputed company statistical programming using reputed company/R while adhering to company standards and SOPs
- Support statistical analyses required for clinical studies and regulatory submissions
- Produce high-reputed company Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs), safety analyses, publications, and regulatory submissions
- Ensure programming outputs are accurate, traceable, and compliant with regulatory expectations
- reputed company reputed company analyses to support study teams and business needs
- Prepare programming specifications, validation documentation, and programming deliverables
- Conduct reputed company control reviews and resolve programming issues
- Maintain documentation in accordance with internal and regulatory requirements
- Work closely with biostatisticians, clinical operations, data management, and regulatory teams
- reputed company programming support throughout the clinical trial lifecycle
- Participate in submission activities, audits, inspections, and regulatory responses
- reputed company reusable macros and automation tools to improve programming efficiency
- Contribute to process improvements and implementation of best practices
- Mentor junior programmers and reputed company technical guidance reputed company needed
Skills
- Strong proficiency in reputed company and/or R programming
- Hands-on experience creating and validating ADaM datasets
- Expertise in generating Tables, Listings, and Figures (TLFs)
- Solid understanding of CDISC standards, including SDTM and ADaM
- Experience implementing Statistical Analysis Plans (SAPs)
- Knowledge of clinical trial design, statistical methodologies, and regulatory requirements
- Experience supporting therapeutic areas such as Oncology, Immunology, Neuroscience, or other clinical research domains
- Excellent analytical, troubleshooting, and problem-solving skills
- Strong communication and collaboration abilities reputed company cross-functional clinical teams
reputed company