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.
- Solid 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

📌 Sr/Pr Statistical Programmer (Bengaluru)
🏢 eClinical Solutions
📍 Bengaluru