Job Description:

We are currently seeking a highly skilled Clinical Data Analyst with expertise in SDTM/ADaM. As a Clinical Data Analyst, your main responsibility will be transforming data into SDTM/ADaM formats for safety and efficacy domains. This will involve reviewing and updating study build specifications, developing utilities and programs, validating ADaM and TLFs, executing validation reports, and ensuring compliance with established processes, SOPs, timelines, and training requirements. Collaboration with the biostatistical team and project manager will be essential, along with active participation in meetings, providing monthly status reports, and proposing process improvements. Adhering to regulations and company policies is a fundamental aspect of this role.

Responsibilities:

• Reviewing and updating study build specifications
• Developing utilities and programs to transform data into SDTM/ADaM for safety and efficacy domains
• Generating and validating ADaM and TLFs using independent programming macros
• Executing the Pinnacle 21 Validation report, resolving errors and warnings
• Following established business processes, SOPs, timelines, and training requirements
• Collaborating and communicating effectively with the biostatistical team and project manager
• Attending meetings and providing monthly status reports
• Identifying opportunities for process improvements while adhering to regulations and company policies

• Bachelor's Degree in a relevant field
• Minimum of 2 years of experience in SAS, Clinical data, SDTM/ADaM, and reporting of clinical data
• General knowledge of Clinical Trials and the Pharmaceutical Industry
• Strong proficiency in English communication

• Stability: Enjoy the reliability of a well-established company
• Comprehensive private healthcare package: Access to a market-leading healthcare plan
• Self-development opportunities: Numerous training programs for personal and professional growth
• Career options: Explore both vertical and horizontal career paths within the organization
• Global and diverse working environment: Experience a friendly atmosphere with relaxing areas
• Engaging activities: Participate in company events, hobby clubs, and sporting initiatives
• Attractive compensation package

Contract Details:

• Type: Full-time, indefinite
• Working hours: 40 hours per week, with a hybrid schedule
• Legal requirements: Must be eligible to work in the specified location