Principal Statistical Programmer

ClinChoice; Roma; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global clinical research organization is seeking a Principal Statistical Programmer Analyst / Consultant to lead project delivery and contribute to programming and compliance. The ideal candidate will have a Bachelor's degree with 8 years of experience in clinical programming or a Master's with 7 years. Proficient in SAS and with strong communication skills, this remote role offers competitive pay. Join a diverse team dedicated to enhancing clinical research practices.

Competenze

• 8 years of clinical programming experience or 7 years with a Master's.
• Knowledge of ICH and Good Clinical Practices.
• Up-to-date knowledge of regulatory requirements.

Mansioni

• Lead overall project delivery or specific technical project.
• Implement statistical programming aspects of development.
• Develop and enhance best practices for quality and efficiency.

Conoscenze

SAS

Clinical trials

Attention to detail

Strong communication skills

Risk management

Stakeholder influence

Project management

Formazione

Bachelor’s degree in computer science, statistics, or related scientific disciplines

Master’s degree in relevant field

Descrizione del lavoro

Position: Principal Statistical Programmer Analyst / Consultant

Employment Type: 12 Month Contract - Extendable

Location: REMOTE

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality, comprehensive services to clients in biopharmaceuticals, medical devices, and consumer products. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. With major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines, we employ over 3,000 professionals worldwide, supporting clinical operations across Asia, North America, and Europe.

Summary

Responsibilities

1. Lead and direct the full scope of project delivery or lead a technical project within the therapeutic area, drug project, study, or function.
2. Implement statistical programming aspects of the protocol or clinical development program.
3. Contribute to cross-functional administrative or process improvement initiatives.
4. Develop and promote best practices to enhance quality, efficiency, and effectiveness within the function.
5. Establish and implement standards.
6. Manage and escalate risks in complex or novel situations within their study or projects.
7. Provide programming expertise to the team.
8. Offer tactical input and drive ideas and improvements.
9. Support recruitment, training, and mentorship within the function.
10. Identify opportunities for methodological improvements and provide practical solutions.
11. Ensure compliance with standards and automation practices.
12. Apply project management practices to manage drug or technical projects.
13. Contribute to capacity management for all projects within scope.
14. Stay current with industry and regulatory requirements.

Qualifications and Experience

1. Bachelor’s degree in computer science, statistics, or related scientific disciplines with 8 years of clinical programming experience; or Master’s degree with 7 years of experience.
2. Knowledge of ICH, Good Clinical Practices, clinical research, clinical trial processes, and regulatory terminology.
3. Understanding of the clinical drug development process.
4. Attention to detail.
5. Strong communication and coordination skills.
6. Ability to communicate independently with global teams.
7. Up-to-date knowledge of technical and regulatory requirements.
8. Proactive management of concurrent activities.
9. Ability to influence stakeholders on programming matters.
10. Risk management skills in complex or novel situations.

Project Mindset

ClinChoice is an Equal Opportunity Employer committed to diversity.

Compensation

Pay: €1.00 - €2.00 per hour

Experience

• SAS: 3 years (required)
• Clinical trials: 3 years (required)