Statistical Programmer II

This is a fully remote position, open to applicants in India.

📋 Description

• Support the coordination of project initiation activities, including the creation of global programs, tracking spreadsheets, and necessary documentation.

• Provide high-value, top-quality statistical programming services for designated projects.

• Generate derived datasets such as SDTM and ADaM, as well as tables, figures, and data listings of varying complexity.

• Conduct quality control on low- to medium-complexity derived datasets, tables, figures, and data listings.

• Aid in the production and quality control of derived dataset specifications, process-supporting documents, and submission materials.

• Enhance and maintain knowledge of local and international regulatory standards within the clinical sector.

• Cultivate skills in SAS and familiarize oneself with processes and procedures within other Parexel functional areas.

• Offer training and guidance to staff and project teams as deemed appropriate.

• Keep study-supporting documentation in accordance with SOPs/Guidelines for traceability and regulatory adherence.

• Ensure compliance with SOPs/Guidelines, ICH-GCP, relevant regulations, and partake in audits and regulatory inspections.

• Engage in initiatives focused on process and quality enhancement.

• Apply regulatory standards related to CDISC, 21 CFR Part 11, and electronic submissions.

⛳️ Requirements

• Possess a degree in a relevant field and/or equivalent professional experience.

• Equivalent professional experience may be accepted in lieu of a degree.

• Strong analytical abilities.

• Proficient in SAS.

• Understanding of the programming and reporting processes.

• Familiarity with SOPs/Guidelines, ICH-GCP, and relevant local and international regulations such as 21 CFR Part 11.

• Capability to learn new systems and adapt in a changing technical landscape.

• Skill in managing competing priorities along with flexibility to adapt.

• Keen attention to detail.

• Ability to effectively collaborate as part of a global team.

• Efficient time management skills to achieve daily metrics or team goals.

• Proficient in both written and spoken English.

• Strong communication skills.

🏝️ Benefits

• Opportunities for professional development and training.

• Competitive salary and benefits package.

• Collaborative and inclusive work environment.

• Exposure to innovative projects and technologies.