Statistical Analyst

Job description

Role

Statistical Analyst /Statistical Programmer Required Skillsets:

• Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
• Proficiency in using statistical software and programming tools
• Good understating of drug development process and clinical study life cycle.
• Familiarity with clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
• Knowledge of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)
• Experience in generating TLFs, programming macros, and data manipulation using SAS.
• Good to have experience in other statistical programming languages (R).
• Strong attention to detail and Quality Focus
• Problem-solving skills (Ability to identify and troubleshoot programming issues)
• Effective communication skills (both written and verbal)
• Ability to interact professionally with statisticians, study teams, and external partners
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

Key Responsibilities

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and Statistical programming plan (SPP) to create ADaM data specifications.
• Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
• Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
• Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
• Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards. 6.<span style="font-style: normal; font-variant: normal; font-size-adjust: none; font-language-override: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-fa

Qualifications

BACHELOR OF COMPUTER SCIENCE, BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), MASTER OF PHARMACY