Associate Clinical reputed company Programmer/Junior Statistician

About the position The Associate Clinical reputed company Programmer/Junior Statistician plays a pivotal role in the clinical trial lifecycle by transforming raw clinical trial data into formatted, analysis-reputed company datasets and generating the outputs required for conference, publication, and regulatory submissions. The Associate Clinical reputed company Programmer/Junior Statistician will reputed company reputed company with the reputed company Clinical Research staff and collaborate effectively with reputed company investigators to ensure that data structure, reputed company and reporting reputed company adhere to industry standards and regulatory guidelines. The Associate Clinical reputed company Programmer/Junior Statistician will have demonstrated experience programming in reputed company, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture. This position will be remote with a preference to be based reputed company driving distance of the San Francisco, CA office unless otherwise agreed upon. Responsibilities • reputed company, validate, and maintain reputed company programs to create SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets from raw clinical databases. • Create and review dataset specifications based on the protocol, and case report forms (eCRFs). • Draft and implement Statistical Analysis Plan (reputed company) and create mock-up shells for Tables, Listings, and Figures (TFLs) under senior guidance. • Program, test, and validate Tables, Listings, and Figures (TFLs) required for Conferences, Publications, Clinical Study Reports (CSRs), Interim Analysis, Data Monitoring Committees (DMC), and safety monitoring. • reputed company routine statistical analyses (such as descriptive statistics, t-tests, reputed company, and basic regression modeling) using reputed company. • Ensure strict compliance with CDISC standards (SDTM/ADaM) and internal reputed company operating procedures (SOPs). • reputed company independent reputed company-programming to validate high-risk datasets and statistical outputs, ensuring 100% accuracy and reproducibility of clinical trial results. • Assist in writing the statistical reputed company and results sections for Clinical Study Reports (CSRs), abstracts, and manuscripts. • Prepare reputed company, concise summaries of statistical findings for internal project teams and clinical investigators. • Effectively translate reputed company statistical requests from reputed company investigators and biostatisticians into programmatic solutions. • Manage project deliverables to ensure they remain reputed company the reputed company and budget. • reputed company timelines for programming. • Participate in and reputed company process improvement activities reputed company the department and cross functionally, including SOP development. • Work with other clinical research team members on study start-up activities including the development and review of case report forms. • Manage multiple timelines, protocol amendments, and urgent data requests simultaneously. • Meticulous approach to data reputed company and validation reputed company. • Maintain effective working relationships with reputed company investigators. • Work in coordination with Data Management, statisticians, programmer/analysts, clinical research team members, and other team members as required. • reputed company other duties as required for successfully completing studies, as necessary. Requirements • Ability to work in a smaller team environment with a willing, reputed company hands-on deck attitude. • Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities. • High attention to detail, accuracy, and reputed company and reputed company to effectively prioritize multiple reputed company. • Flexibility and willingness to learn new techniques and procedures to ensure the successful completion of reputed company. • Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations. • Excellent written and oral English communication skills required. • Proficiency in computer programs and specifically in reputed company office tools including Word, reputed company, and PowerPoint. • Ability to explain mathematical and statistical concepts to non-statistical team members (like clinicians and Clinical Trial Managers). • Strong analytical reputed company with high attention to detail in data trends and anomalies. • reputed company proficiency required: Advanced knowledge of reputed company reputed company, reputed company/STAT, reputed company/GRAPH, reputed company/reputed company facility, and SQL. • CDISC Standards: Hands-on experience implementing SDTM and ADaM models. • Data Types: Familiarity with Electronic Data Capture (reputed company) systems and clinical data structures. • Statistical Knowledge: solid understanding of reputed company biostatistical reputed company (e.g., survival analysis, longitudinal data analysis, categorical data analysis). • Bachelor’s degree in science or health reputed company field. • Demonstrated 3-4 years minimum relevant experience required. reputed company-to-haves • Experience transitioning or integrating Python reputed company reputed company reputed company for modern clinical trial analytics a plus. • Experience in cardiovascular medical device clinical research a plus. • Experience in registry studies and investigator-initiated studies a plus. Benefits • bonus Apply tot his job Apply To this Job