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Domain ExperienceRequiredClinical TrialsDirect ClientStart Date February 2023Duration 6 months – 960 hoursHours Per Week 40 hours per week
Client Location Remote – CSTWorking Location RemoteCitizenship Requirements Candidates must be legally authorized to work in the UnitedStates.DESCRIPTION and RESPONSIBILITIESSAS is seeking a full time Senior SAS Clinical Trials Programmer to work with our client, aClinical Research Organization client.This Consultant will be acting as programming lead on studies responsible forresourcing, communication with Statistician, DM, vendors and clients, performingdeliveries. SAS will provide analytical services in support of customer’s clinical researchstudies and FDA submission process.Consultant will provide programming/analytical support utilizing SAS as the primaryprogramming language to create and manage the production of analysis reports, summarytables/listings and graphs for clinical trials submitted to various regulatory bodies worldwide.The consultant must have excellent communication skills and must be able to communicateabout the techniques developed and results of analysis both to executives and other analysts inthe organization.QUALIFICATIONS – ESSENTIAL• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics,Computer Science, Mathematics, etc. Healthcare or technology related field.• 8+ years of SAS programming experience working with clinical trials data in thePharmaceutical & Biotech industry.2• To perform the lead programming role, lead continuous improvement in the programmingfunction’s operating systems and provide consultancy across the function• SAS certifications (Base, Advanced, etc.) are highly desired. Be proficient in Base SASprogramming (DATA step), SQL programming (i.e., use of SQL pass-through or PROCSQL), as well as the SAS Macro language for use in making code more efficient.• Familiarity with programming to generate summary statistics (mean, median, etc.) andcomplex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).• CDISC data models a necessity, especially SDTM then ADaM• CDISC knowledge• SDTM and ADaM dataset experience• Good written and spoken communications skills in English and thought-leadership skills.MAJOR RESPONSIBILTIES/ACTIVITIES:• Develop, test and execute SAS programs to produce and validate CDISC SDTM andADaM datasets, tables, figures and listings (TFL).• Perform review and provide guidance on the development of the clinical databasespecification, data transfer agreement/specification, specification of tables, figures andlistings (TFL) shells.• Develop and review specification for SDTM datasets and ADaM datasets for safetydata, TFL shells and other specifications, e.g. patient profiles, OPS reports.• Develop and review electronic data submission package (SDTM annotated CRF,define.xml, Study/Analysis Data Reviewer's Guide) for high complexity studies.• Serve as a programming project lead on a complex study (e.g. adaptive design,integrated safety/efficacy study) to distribute and oversee tasks for the programmingteam, communicate with internal and external clients, plan and execute delivery, andmanage resources and competing project priorities effectively. Ensure budget andscope of project work remain aligned.• Manage the study documentation flow as per Worldwide SOP and other proceduraldocumentation including timely document submission to eTMF. Be able to describeand explain Worldwide documentation and eTMF requirements.• Contribute to department process improvement including creating and testingstandard SAS Macros, maintaining the required validation documentation.• Provide consultancy to Clinical Data Managers, Statistical Programmers andBiostatisticians on programming, clinical and analysis data standards (CDISC) andelectronic data submission requirements.• Develop and provide Statistical Programmers with training and coaching on theBiostatistical Operations department process, infrastructure and tools, collaborationwith other internal and external parties and the role of the statistical programmer.• Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) andother software applications (e.g. Excel, Visual Basic, Word). Develop regulatorystandards knowledge in computer systems, systems validation, Good Clinical• Practice, clinical data management, clinical/statistical reporting and regulatorysubmission requirements etc.• Act as subject matter expert for internal and external quality audits and inspections.• Ensure all activities performed by the study team are in compliance with Worldwide3and sponsor quality requirements, relevant ICH and regulatory authority standards,e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR).• Act as a mentor for junior department members.- ID: #49064580
- State: Texas Dallas / fort worth 75201 Dallas / fort worth USA
- City: Dallas / fort worth
- Salary: $50 - $60
- Job type: Contract
- Showed: 2023-02-07
- Deadline: 2023-03-27
- Category: Et cetera