Principal Statistical Programmer - ONCO - Late Phase
Location
Slough, Berkshire | United Kingdom
Job description
Principal Statistical Programmer - ONCO - Late Phase
at ClinChoice (View all jobs)
European Union
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.
Summary The Principal Statistical Programmer/Consultant is accountable for quality, timely and efficient delivery of projects, programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the Programming discipline. As an expert within their own field, acts as a specialist within cross-functional teams to deliver continuous improvement.
Main Job Tasks and 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
- Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function.
- 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
- Influences stakeholders by providing subject matter expertise on programming-related items
- Ensures compliance with 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 in 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. of clinical programming(CDISC) experience; Master’s degree in CS, statistics, or related disciplines with 7 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.
- Detail oriented.
- Strong communication skills and coordination skills.
- Can communicate with the global team independently.
- 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
Specific Role Requirements and Skills: - Experience with oncology clinical trials and protocols.
- Experience in late-phase studies
- Familiarity with CDISC standards
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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