Description:
Location: Italy - home based
Schedule: Full-time, permanent
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Principal Statistical Programmer Analyst to join a global pharmaceutical company in Italy.
CROMSOURCE is an international 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 their client counterparts.
The Principal Statistical Programmer Analyst/Consultant is accountable for the 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. Must have experience working with oncology trials.
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 escalates 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.
Education and Experience:
- Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 years of clinical programming experience; Master's degree in CS, statistics, or related disciplines with 7 years of clinical programming 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 global teams independently.
- Experience with oncology trials.
The Benefits of Working in Italy:
- Meal vouchers
- Mobile phone if requested by the Line Manager
- Dedicated Line Manager
- Monthly meetings with the line manager
- Full performance and development process with end-of-year reviews
- Team events and end-of-year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement.
The Application Process
Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a 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.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com please contact mailto:careers@cromsource.com for more information.
Who will you be working for?
About CROMSOURCE
CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Principal Statistical Programmer Analyst/Consultant, Consultant, Oncology, Respiratory, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, SAS programming, data analytics, statistics, statistical analysis, clinical trials, SQL, Microsoft Excel, Macros, HTML, ODS, operational data store, programming
Skills:
Oncology, Data Analyst, Principal Biostatistician, Programmer Analyst, SAS Programmer, clinical trials, CRO, Data Analysis, Programming, SQL