Clinical sas programmer

Job Description

clinical sas programmer- ahmedabad* * * Responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical team. * Responsible for all statistical tasks on assigned projects/trials, and perform these tasks independently seeking clinical team input/review as required. Responsible for protocol development in alignment with the development plan, Sample size estimation, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the industry standards. * Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission report activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. * Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent CBCC in statistical discussions at external congresses, conferences, scientific meetings. * Represent the Biostatistics Line Function on cross-functional teams for the assigned projects/trials. * Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, as required. * Establish and maintain sound working relationships and effective communication within the Project Team and Biostatistics teams. * Contribute to project level activities as needed. * Contributes to project team preparation for HA Advisory Committees and meetings. * Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. * Propose and implement innovative designs and methods to optimize dose finding and drug development. * Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. * Significantly contributes to project team preparation for HA Advisory Committees and meetings. * * * Provide timely and professional on-going management of Clinical SAS programming deliverables and of data outputs with respect to quality and timelines for assigned studies managed within Data Sciences and as in compliance with CBCC applicable SOPs. * * * Build SAS datasets from clinical database. * Develop SAS macros, templates and utilities for data cleaning and reporting. * Utilize SDTM guidelines to build datasets. * Communicate with an internal team to create deliverables for pharmaceutical and biotechnology clients. * Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician. * Write and validate SAS programs to generate tables, listings, and figures and analysis datasets. * Review CRF annotations and data specifications. * Work in tandem with Biostatistics and Data Management member on various clinical projects. * Identify and edit checks per the data validation plan or data management plan. * Study management reports using SAS. * Perform analyses defined in the statistical analysis. * Prepare statistical summary reports. * Communicate with programming and statistics leads. * Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting. * Perform quality control on final statistical reports. * Develop SAS coding and table templates for preparing, processing and analyzing clinical data. * Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on project level activities. * As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, listings, summaries, figures and tables for the clinical project * Program, according to specifications, analysis datasets, listings, tables, and figures for clinical projects and/or apply standard statistical methods to standardized PK study designs * Track milestones for project deliverables. * Maintain records for all assigned deliverables including archiving of project analysis and associated documentation. * Comply with pre-defined project / study standards and specifications. * Begins to develop a working knowledge of drug development and approval process * Other duties as assigned by reporting head or management skillsSAS Programmer qualificationB-Pharma,

Keyskills :
sassdtmprogrammingclinical sas programmingstatistical analysis planssas macrosdata cleaningquality controldata managementdata validationsas programming