Senior SAS Clinical Trials Programmer

2 months ago

Austin, United States Della Infotech Full time

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).

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