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.
Overview
Statistical Programmers provide SAS programming expertise in data extracted from various databases for data transformation of raw data. Develop specifications and programming expertise and validation for Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and develop programming to produce Tables, Listings and Graphs/Figures (TLGs or TLFs) and other reports to support statistical analysis.
Key Tasks & Responsibilities
- Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis.
- Develop SAS programming to produce SDTM datasets and SDTM datasets.
- Develop specifications for Analysis Data Model (ADaM) datasets.
- Develop SAS programming and validation of ADaM datasets for trial level reporting and integrated safety and efficacy activities.
- 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 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 and 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
- Mentor statistical programmers
- Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.
- Other duties as assigned.
Education/ Language
- Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related field, computer science or equivalent.
- SAS Certified
- Excellent knowledge of English
Professional Skills & Experience
- Minimum 6 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role
- Strong experience in preparations for NDA filings
- Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies
- Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
- 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
- Strong experience of 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
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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.
