Principal Statistical Programmer

2 settimane fa


Roma, Italia ClinChoice A tempo pieno

**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 one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

**Summary**

**Responsibilities**
- Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function
- Leads Implementation of statistical programming aspects of the protocol or clinical development program
- Leads or contribute to cross-functional administrative or process improvement initiative(s)
- Drives the development of best practices to improve quality, efficiency and/or effectiveness within the function
- Drives standards development and implementation
- Manages and escalate risk in complicated or novel situations within their study and/or projects
- Provides Programming expertise to the team
- Provides tactical input and/or drives ideas and improvements
- Contributes to the function by supporting recruiting and/or providing training and mentorship
- Identifies opportunities to improve methodology and provides practical solutions for problems
- Ensures compliance to standards and automation usage
- Employs all project management practices in managing drug or technical projects
- Provides input to capacity management for all projects in scope
- Maintains expertise of the latest industry and regulatory requirements to stay current

**Qualifications and Experience**
- Bachelor’s degree in computer science (CS), statistics or related scientific disciplines with 8 yrs. clinical programming experience; Master’s degree in CS, statistics or related disciplines with 7yrs. of clinical programming experience.
- Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Good understanding of clinical drug development process.
- Detail oriented.
- Strong communication skills and coordination skills.
- Can communicate with global team independently.

**Confidential for Review Purposes Only**
- Current knowledge of technical and regulatory requirements relevant for the role
- Ability to proactively manage concurrent activities within a project
- Proficient ability to influence relevant stakeholders on programming related items
- Ability to manage risk in complicated or novel situations
- Project Mindset

**Clinchoice is an Equal opportunity Employer/committed to diversity**

Pay: €1.00 - €2.00 per hour

**Experience**:

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



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