Senior Statistical Programmer

• Assists clinical team in designing clinical trials and preparing statistical sections of clinical study protocols and statistical analysis plan.
• Reviews and tests electronic data capture system, Case Report Forms, TFLs shell and specification to ensure consistency with study protocol and clinical requirements.
• Reviews study data management documents (Data Management Plan, EDC System User's Guide, etc.) prepared by CROs.
• Ensures timely and accurate delivery of TFLs and completeness of study data captured in an electronic database.
• Collaborates with vendors, specialty labs, and CROs in timely and accurate transfer of study data.
• Produces tables and listings in R or SAS for clinical study reports, interim reports, and ad-hoc reports.
• Supports clinical and non-clinical team in performing ad-hoc statistical analysis with visualizing data in R and SAS
• Interprets clinical trial data and contributes to preparation of clinical manuscripts and regulatory submission documents.
• Responsible for storing and organizing clinical study data on company servers.

Requirements:

• Proficient with R and SAS (Base SAS, SAS/STAT, SAS Macro and SAS SQL) programming
• SAS Certified Base Programmer and Advanced Programmer are preferred, but not required.
• Knowledge of MS Excel, Word, Access, and PowerPoint is essential.
• Experience with study design and application of statistical methods for clinical trials
• Experience with CDISC standard datasets (SDTM and ADaM) is desirable.
• Excellent organizational and communication skills and strong attention to details
• Ability to manage multiple tasks and work independently.