Principal Statistical Programmer /Analyst Consultant

ClinChoice; Pennsylvania; On-site; USD 140,000 - 190,000; Full time

Job summary

ClinChoice is a global, full-service CRO seeking a Principal Statistical Programmer Consultant to lead programming efforts for client studies. You will work under a Programming team leader to deliver technical programming components with high-quality standards.

Required are advanced CDISC expertise, ICH/GCP knowledge, and strong communication and coordination abilities to influence stakeholders and ensure compliant, efficient program delivery.

Qualifications

• Bachelor's degree in CS, statistics, or related disciplines with 5+ years in CDISC-based clinical programming.
• Master's degree in CS, statistics, or related disciplines with 6+ years in CDISC-based clinical programming.
• Working knowledge of ICH/GCP, clinical research processes, and regulatory terminology.
• Strong communication and coordination skills; ability to influence stakeholders.

Responsibilities

• Lead and/or support programming deliverables for clinical studies or projects.
• Implement statistical programming aspects of protocols and development programs.
• Ensure high quality in own deliverables and in teammate outputs; write specifications.
• Program independently with efficiency and quality; develop and maintain documentation.
• Contribute to best practices to improve quality, efficiency and automation usage.
• Plan and support team activities; communicate risks to study leadership.
• Collaborate with statisticians, data managers, and study leads to ensure integrated programming.

Skills

CDISC

Clinical programming

Communication

Coordination

Regulatory knowledge

ICH/GCP

Education

Bachelor's degree in CS or statistics or related

Master's degree in CS or statistics or related

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.

Main Job Tasks and Responsibilities

The Principal Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks

Key Responsibilities

• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.
• Programs independently with high efficiency and quality.
• Writes and/or implements specifications and oversees completeness of relevant documentation.
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
• Ensures compliance with standards and automation usage.
• Plans and support team activities and tasks.
• Communicates and escalates risks within the assigned studies and/or projects.
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Education and Experience

• Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
• Good understanding of the clinical drug development process.
• Strong communication skills and coordination skills.
• 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

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.