1030# Principal Statistical Programmer Consultant- Immunology-Early phase development (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 Programmer Consultant to join one of our clients in Immunotherapy 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. Main Job Tasks and Responsibilities: The Principal Statistical Programmer consultant will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report and regulatory submission. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks. Note: require experience with the following

• Immunology experience – background in working with immune system-related diseases.
• Lupus experience – ideally, experience in working on studies or treatments related to Lupus (a specific autoimmune disease).
• Early phase development experience – experience working on Phase I or Phase II clinical trials, which are early stages in drug development focused on safety, dosing, and initial efficacy.

Key Responsibilities:

• Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs.
• Capacity for independent programming and review of reports and outputs.
• Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians.
• Responsible for supporting the Programming deliveries of a clinical study or project.
• Programs independently with high efficiency and quality.
• 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.

Education and Experience:

• Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 10 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 8 yrs. of clinical programming (CDISC) experience.
• Immunology TA experience is required.
• ISS & ISE experience is required.
• 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

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. #LI-TT1 #LI-Remote #Principal#Contract Apply tot his job Apply To this Job