Sr/Pr Statistical Programmer

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

Skills Required
Proc Sql, Sas Stat, Ods, statistical programming, Sas, Pharmaceutical