Principal Statistical Programmer – Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)

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 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.  

We are seeking a Principal Statistical Programmer to join our growing team in Late Phase Clinical - Cardiovascular, Renal, and Metabolism (CVRM). This is a leadership role responsible for the strategic direction and delivery of programming activities across complex clinical development programs. As a subject matter expert, you will guide teams in the implementation of statistical programming and provide technical leadership across a range of drug development projects.

You will be expected to lead the full scope of programming activities, ensuring the highest quality deliverables and efficient project delivery, while driving continuous improvement within the programming discipline.

Main Job Tasks and Responsibilities:

• Leading and directing the full scope of programming delivery for projects or technical initiatives within the CVRM therapeutic area, ensuring alignment with project timelines, quality standards, and objectives.
• Implementing statistical programming aspects of clinical protocols or development programs, providing expert guidance to the team and ensuring proper execution.
• Ensuring the high quality of all project deliverables, holding external partners and providers accountable for their contributions, and acting as a technical subject matter expert for specific therapeutic areas, projects, or functions.
• Driving the development of best practices in programming to improve quality, efficiency, and effectiveness within the function, fostering innovation in programming methodologies.
• Leading or contributing to cross-functional process improvement initiatives, bringing forward solutions that enhance overall team performance.
• Driving the development and implementation of programming standards, ensuring consistency and compliance across projects.
• Managing and escalating risks in complex or novel situations, particularly in projects that may involve new technologies or methodologies.
• Providing expert programming guidance and support to project teams, influencing stakeholders on programming-related issues.
• Ensuring compliance with industry standards and regulatory requirements, and promoting the use of automation tools in the programming workflow.
• Managing drug or technical projects using proven project management practices, ensuring timely delivery and quality results.
• Contributing to capacity management for all projects within scope, optimizing resource allocation to meet project demands.
• Maintaining expertise in the latest industry, regulatory, and technical requirements to ensure programming activities are up-to-date and compliant.

Qualifications and Experience:

• Bachelor’s degree in Computer Science (CS), Statistics, Mathematics, or related scientific field.
• 8+ years of SAS programming experience, with 4+ years of experience in Cardiovascular, Renal, and Metabolism (CVRM) clinical trials.
• In-depth experience with CDISC standards (SDTM, ADaM) and an understanding of their application in clinical trials.
• Working knowledge of ICH and Good Clinical Practices (GCP), clinical research processes, and related regulatory requirements.
• Strong understanding of the clinical drug development process and experience with late-phase studies.
• Excellent communication and coordination skills, with the ability to interact with global teams and stakeholders independently.
• Proficient in risk management for complex or novel situations, demonstrating the ability to proactively address challenges.
• Proven ability to influence relevant stakeholders, ensuring effective decision-making on programming-related matters.
• Experience with programming leadership in cross-functional teams, driving project success and providing mentorship to junior staff.

Specific Role Requirements and Skills:

• Extensive experience with CVRM clinical trials and protocols, with a focus on driving programming activities in this therapeutic area.
• Experience in late-phase studies, with the ability to take full ownership of complex datasets, TLFs (Tables, Listings, Figures), and statistical deliverables.
• Strong time management and communication skills, with experience in managing concurrent activities and leading project teams to successful outcomes.
• Familiarity with CDISC standards and their application in clinical trial data.
• Ability to lead and mentor junior programming staff, contributing to the development of talent within the organization.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

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.

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