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Principal Statistical Programmer

3 months ago

Remote, Oregon, United States eClinical Solutions Full time

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

OVERVIEW

Principal Statistical Programmers work with Principal Technical Consultant to provide SAS programming in data extracted from various databases. Principal Statistical Programmers document and program for the transformation of raw data to Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and develop programming to produce Tables, Listings and Graphs/Figures (TLGs or TLFs).

KEY TASKS & RESPONSIBILITIES

Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming Develop re-usable utility macros in order to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting Collaborate with the project team to ensure the deliverables are completed on time with high quality Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC Maintain all project documentation as required by SOP and Processes Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures Other duties as assigned

CANDIDATE'S PROFILE

Education/ Language:

Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related field, computer science or equivalent preferred Excellent knowledge of English

Professional Skills & Experience

10+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred Strong experience in preparations for NDA filings Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) Expert knowledge of CDISC related data models like SDTM, and ADAM. Experience of working on multiple clinical protocols at the same time. Excellent verbal and written communication skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Excellent team player

Technical Skills & Experience

Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures Expertise in base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must. Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate. Strong experience in SAS programming in various phases of clinical trial. Experience in pooled data analysis and programming. Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values. Experience in working with relational databases and performance tuning of SAS programming Experience with writing batch scripts and/or shell scripts is a plus

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours

eClinical is a winner of the 2023 Top Workplaces USA national award We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here:

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.