Are you passionate about clinical data analysis and looking for a promising career in statistical programming? Parexel, a global leader in clinical research and data services, is offering an exciting opportunity for a Statistical Programmer-II (FSP) in Hyderabad, India. This role involves analyzing, summarizing, and presenting clinical data to expedite the development of life-saving treatments.
Company Introduction
Parexel is a renowned organization in the clinical research and biopharmaceutical industry, providing end-to-end solutions for clinical trials and drug development. Known for fostering innovation, quality, and collaboration, Parexel empowers employees to grow through extensive training, mentoring, and a supportive work environment.
Responsibilities in the Job
As a Statistical Programmer-II, you will play a critical role in clinical trial programming and data analysis. Key responsibilities include:
1. Project Management:
- Coordinating project start-up activities.
- Creating global programs and documentation.
- Tracking and maintaining project spreadsheets.
2. Statistical Programming:
- Delivering high-quality, efficient programming solutions.
- Producing and QCing derived datasets (e.g., SDTM, ADaM), tables, figures, and listings.
- Supporting the creation of dataset specifications and submission documentation.
3. Training and Mentorship:
- Developing regulatory knowledge and technical expertise.
- Providing mentorship and training to team members as needed.
4. General Compliance:
- Ensuring adherence to SOPs, ICH-GCP, and regulatory requirements.
- Participating in audits and regulatory inspections.
- Proactively contributing to quality improvement initiatives.
Qualifications
Candidates must meet the following criteria:
- A degree in a relevant field or equivalent work experience.
- Strong understanding of clinical industry regulations like CDISC and 21 CFR Part 11.
- Proficiency in SAS programming and related tools.
- Knowledge of clinical trial data processes and industry standards.
Skills
To excel in this role, you should possess:
- Technical Skills: Proficiency in SAS and clinical trial programming processes.
- Analytical Skills: A detail-oriented approach and ability to interpret complex data.
- Communication Skills: Competency in written and oral English for effective team collaboration.
- Time Management: Capability to manage multiple priorities and meet deadlines.
- Teamwork: A proactive, quality-focused attitude with a commitment to global team success.
