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
As the Principal Statistical Programmer, you will work with the Principal Technical Consultant and provide SAS programming expertise in data extraction from various databases, TLG programming, developing programming and validation specifications. You will provide hands-on expertise in programming SDTM and ADaM datasets to support various analyses and TLG Programming. You will be responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
KEY TASKS & RESPONSIBILITIES
- Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials
- Develop analysis datasets for trial level reporting and integrated safety and efficacy activities
- 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
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
- 7+ 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)
- 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
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 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.
