What are the responsibilities and job description for the Senior SDTM Programmer Consultant_Hybrid@NJ/PA position at ClinChoice Inc.?
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.
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.
ClinChoice is searching for a Senior SDTM Programmer Consultant to join one of our clients.
Location : Hybrid / Onsite preferable. If remote, the candidate must be in the East Coast time zone.
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 Senior Study Data Tabulation Model (SDTM) Statistical Programmer provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and validation of study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards. The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards deliverables and providing tools and templates to assist delivery focusing on traceability, quality assurance, data conformance, and data fitness. The position is a key collaborator with statistical programming, statistics, global data management, and other project stakeholders. New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Key Responsibilities :
- Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
- Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
- Up-versioning activities to specific versions of SDTM.
- Partner effectively with project team members.
- Participation in industry teams and conferences on best practices.
- Membership on departmental strategic initiative project teams.
Education Minimum Requirements :
Required Experience and Skills :
Preferred Experience and Skills :
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 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.
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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