Life Sciences - Mumbai City, Navi Mumbai, Mumbai - Outpace Consulting Services

Description

Outpace Consulting Services is seeking a talented Clinical SAS + SQL Programmer with expertise in Life Sciences for a leading ITES company. This role is crucial for statistical programming within the clinical domain, focusing on the development and validation of analysis datasets, tables, listings, and figures. You will ensure compliance with ICH-GCP guidelines and CDISC standards, contribute to both safety and efficacy parameter analysis, and provide critical support in the clinical drug development process.

Key Responsibilities:

• Data Specification & Derivation: Create derived data specifications in accordance with CDISC SDTM, ADaM, and TLF standards, including those for pooled analysis (ISS/ISE) datasets.
• Programming & Validation: Perform the development and/or validation of analysis datasets, tables, listings, and figures for both safety and efficacy parameters.
• Project Leadership: Serve as the project lead for statistical programming projects, understanding and complying with ICH-GCP guidelines, core operating procedures, and work instructions.
• Quality & Compliance: Ensure all programs are compliant with Standard Operating Procedures (SOPs) and project-specific guidelines. Maintain the quality and adherence to timelines for all programming-related deliverables.
• Support & Development: Provide support in developing ad hoc reports as required. Develop study-level macros as directed by Senior / Lead Statistical Programmers.
• Issue Management & Communication: Track and follow up on all issues raised, escalating unresolved issues to the project point of contact. Communicate any data queries or errors to appropriate team members.
• Documentation: Regularly update all project-related documentation.
• Escalation Handling: Handle escalations related to projects.

Required Qualifications:

• Experience: Minimum 3 years of experience in the Clinical domain is mandatory.
• Experience in Statistical Programming in the clinical domain.
• Experience and understanding of ICH-GCP principles and the clinical drug development process.
• Technical Knowledge:Good knowledge of CDISC SDTM, ADaM & TLF standards.
• Proficiency in Clinical SAS programming (implied by the role title and responsibilities).
• Proficiency in SQL programming (as per the role title).
• Education: Bachelor's or Master's degree or equivalent in statistics, mathematics, engineering, or a computer-related subject.

To Apply: WhatsApp 'Hi' to Then, follow these steps:

1. Click on the 'Start' option to Apply and fill your details.
2. Select the location as 'Other' (to get multiple location options).
3. Type: Job Code #284 for Mumbai.