Senior SAS Clinical Trials Programmer
2 months ago
Job Title
Senior SAS Clinical Trials Programmer
Domain Experience Required
Clinical Trials
Client
CRO Client
Start Date
February 2023
Duration
6 months - 960 hours
Hours Per Week
40 hours per week
Client Location
Remote - CST
Working Location
Remote
Citizenship Requirements
Candidates must be legally authorized to work in the United States.
DESCRIPTION and RESPONSIBILITIES
seeking a full time Senior SAS Clinical Trials Programmer to work with our client, a Clinical Research Organization client.
This Consultant will be acting as programming lead on studies responsible for resourcing, communication with Statistician, DM, vendors and clients, performing deliveries. SAS will provide analytical services in support of customer's clinical research studies and FDA submission process.
Consultant will provide programming/analytical support utilizing SAS as the primary programming language to create and manage the production of analysis reports, summary tables/listings and graphs for clinical trials submitted to various regulatory bodies worldwide.
The consultant must have excellent communication skills and must be able to communicate about the techniques developed and results of analysis both to executives and other analysts in the 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 the Pharmaceutical & Biotech industry.
• To perform the lead programming role, lead continuous improvement in the programming
function's operating systems and provide consultancy across the function
• SAS certifications (Base, Advanced, etc.) are highly desired. Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient.
• Familiarity with programming to generate summary statistics (mean, median, etc.) and complex 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 and ADaM datasets, tables, figures and listings (TFL).
• Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) shells.
• Develop and review specification for SDTM datasets and ADaM datasets for safety data, 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 programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively. Ensure budget and scope of project work remain aligned.
• Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF. Be able to describe and explain Worldwide documentation and eTMF requirements.
• Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation.
• Provide consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements.
• Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer.
• Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical
• Practice, clinical data management, clinical/statistical reporting and regulatory submission 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 Worldwide
and sponsor quality requirements, relevant ICH and regulatory authority standards,
e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR).
-
Senior SAS Clinical Trials Programmer
4 weeks ago
Austin, Texas, United States Della Infotech Full timeJob Title: Senior SAS Clinical Trials ProgrammerJob Summary: Della Infotech is seeking a highly skilled Senior SAS Clinical Trials Programmer to join our team. As a Senior SAS Clinical Trials Programmer, you will be responsible for developing, testing, and executing SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures, and...
-
Clinical Trials Programmer Lead
7 days ago
Austin, Texas, United States Della Infotech Full timeClinical Trials Programmer Lead PositionAt Della Infotech, we are seeking a skilled Clinical Trials Programmer Lead to join our team. The successful candidate will be responsible for leading programming projects, ensuring high-quality deliverables, and collaborating with cross-functional teams.Key Responsibilities:Lead programming projects, including...
-
Senior Scientific Associate, Bioanalysis
2 months ago
austin, United States Worldwide Clinical Trials Full timeWho we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
Senior Scientific Associate, Bioanalysis
2 months ago
austin, United States Worldwide Clinical Trials Full timeWho we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
Senior Scientific Associate, Bioanalysis
2 months ago
Austin, United States Worldwide Clinical Trials Full timeWho we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
Senior Scientific Associate, Bioanalysis
4 months ago
Austin, United States Worldwide Clinical Trials Full timeWho we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
Senior Scientific Associate, Bioanalysis
2 weeks ago
Austin, TX, United States Worldwide Clinical Trials Full timeWho we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
Test Analyst
3 weeks ago
Austin, United States Worldwide Clinical Trials Full timeWho we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global...
-
Senior Trial Attorney
4 weeks ago
Austin, Texas, United States Nationwide Full timeJob DescriptionWe are seeking a highly skilled and experienced Senior Trial Attorney to join our team at Nationwide. As a key member of our Legal team, you will be responsible for representing clients under both commercial and personal lines insurance policies independently as lead counsel, as well as part of a larger team as needed.Key...
-
Senior Backend Programmer
1 month ago
Austin, Texas, United States Arkane Studios Full timeAbout the RoleWe are seeking a highly skilled Senior Backend Programmer to join our team at Arkane Studios.ResponsibilitiesAs a Senior Backend Programmer, you will be responsible for designing, implementing, and maintaining high-performance, scalable, and secure backend systems in Go. Your key responsibilities will include:Implementing and testing...
-
Developer/Programmer Analyst 3
3 days ago
Austin, United States TriOptus LLC Full timeI. DESCRIPTION OF SERVICESClient requires the services of 1 Developer/Programmer Analyst 3, hereafter referred to as Candidate(s), who meets the general qualifications of Developer/Programmer Analyst 3, Applications/Software Development and the specifications outlined in this document. All work products resulting from the project shall be considered "works...
-
Senior Trial Attorney
3 months ago
austin, United States Kirker Davis LLP Full timeQualifications: Texas law license. 5+ years of trial work in family law. The right candidate will have a desire to provide the highest quality legal work and be a team player that knows the benefit of working in alignment with other talented professionals.
-
Senior Trial Attorney
5 months ago
Austin, United States Kirker Davis LLP Full timeQualifications: Texas law license. 5+ years of trial work in family law. The right candidate will have a desire to provide the highest quality legal work and be a team player that knows the benefit of working in alignment with other talented professionals.
-
Senior Trial Attorney
3 months ago
austin, United States Kirker Davis LLP Full timeQualifications: Texas law license. 5+ years of trial work in family law. The right candidate will have a desire to provide the highest quality legal work and be a team player that knows the benefit of working in alignment with other talented professionals.
-
Clinical Research Associate III-Senior
1 day ago
Austin, United States WuXi AppTec Full timeOverview: WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise...
-
Senior Transparency Specialist
1 month ago
Austin, United States MMS Full timeJob OverviewAt MMS, we're seeking a highly skilled Senior Transparency Specialist to join our team. As a key member of our clinical research organization, you'll play a crucial role in ensuring the transparency of our clinical trials. Your expertise will be instrumental in providing high-quality transparency deliverables, ensuring compliance with evolving...
-
Clinical Research Associate III Senior
1 month ago
Austin, Texas, United States WuXi AppTec Full timeJob SummaryThe Senior Clinical Research Associate is a critical position within the Operations team, responsible for managing clinical trial studies and partnering with Project Managers to support complex/larger trials.Key ResponsibilitiesCoordinate clinical study timelines to meet critical milestones and escalate issues that may jeopardize timelines and...
-
Senior Evaluation and Research Scientist
1 month ago
Austin, Texas, United States TEXAS EDUCATION AGENCY Full timeJob Summary:This role is for a Senior Evaluation and Research Scientist within the Evaluation Activities unit of the Division of Research and Analysis. The ideal candidate will have a strong background in SAS programming, research, and statistical analysis, with a minimum of four years of experience in these areas.Key Responsibilities:Perform advanced and/or...
-
Senior FP&A Manager
6 days ago
Austin, United States Prelude Services Full timeAbout Prelude is a life science technology company looking to make the world safer and healthier by accelerating new product development of life-saving medicine and devices for humans and animals. Our mission is to simplify clinical research through smarter technology and superior service. Clinical trial designs are becoming increasingly complex, making new...
-
Clinical Services Assistant Director
4 weeks ago
Austin, Texas, United States Brookdale Senior Living Full timeJob Title: Clinical Services Assistant DirectorBrookdale Senior Living is seeking a highly skilled Clinical Services Assistant Director to join our team. As a key member of our clinical leadership team, you will be responsible for planning, organizing, and directing the day-to-day operations of the Clinical Services department.Key Responsibilities:Assess the...