950# Principal/Lead Statistical Programmer Consultant (Cardiovascular)-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 searching for a Principal/Lead Programmer Consultant to join one of our clients in Cardiovascular TA Team. 

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.  

Job Overview

The Principal/Lead Statistical Programmer will serve as a key technical expert in the design, implementation, and delivery of statistical programming activities in support of clinical trials and regulatory submissions. This highly skilled role involves hands-on programming, advanced technical problem-solving, and leading cross-functional collaboration on complex statistical deliverables. The Principal Programmer will ensure high-quality programming outputs in compliance with industry standards and regulatory requirements, while also contributing to innovation in tools, processes, and infrastructure (e.g., Statistical Computing Environment, SCE).

This role acts as a critical technical interface between Biostatistics, Clinical Data Management (CDM), and other functions, driving consistency, efficiency, and quality across study and program-level deliverables.

Essential Duties and Responsibilities

Project Responsibilities:

• Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables.

• Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests.

• Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity.

• Provide expert input and review of programming assumptions, table shells, and analysis specifications.

• Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking.

• Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications.

• Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management.

Strategic and Initiative Responsibilities:

• Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality.

• Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management.

• Evaluate and implement innovative tools and programming technologies to streamline processes.

• Act as a subject matter expert (SME) during audits and inspections, with the ability to explain programming strategies and methodologies to regulatory agencies.

Qualifications and Preferred Skills
Education:

• Master’s degree in Statistics, Biostatistics, Computer Science, or a related field.

Experience:

• Minimum of 8 years of statistical programming experience in the pharmaceutical, biotech, or CRO environment.

• Expert-level SAS programming skills; proficiency in R is highly desirable.

• Deep understanding and hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements.

• Strong knowledge of statistical concepts, clinical trial design, data standards, and regulatory expectations (e.g., FDA, EMA, PMDA).

• Proven ability to independently produce high-quality analysis datasets, tables, listings, and figures for regulatory and publication purposes.

• Experience in working with tools like Pinnacle 21, define.xml, and other clinical data standards tools.

• Demonstrated ability to collaborate effectively in cross-functional settings and manage competing priorities in a fast-paced or startup environment.

• Prior experience with regulatory audits and inspections is a plus.

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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