Senior SDTM Programmer/Analyst Consultant_Hybrid@NJ/PA
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 Senior SDTM Programmer Consultant to join one of our clients.
Location: NJ/PA - 3 days Hybrid
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:
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 5 years SAS programming experience in a clinical trial environment.
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 3 years SAS programming experience in a clinical trial environment.
Required Experience and Skills:
- Strong SAS programming skills with demonstrated experience in macro development.
- Demonstrated experience in CDSIC standards with strong command in SDTM.
- Effective interpersonal skills and ability to negotiate and collaborate effectively. Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings). Accountable for tasks at project level; ability to partner with key stakeholders. US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
- Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.
- Demonstrated success in the assurance of deliverable quality and process compliance. Excels in technical writing, able to convert complex ideas and information into simple readable form.
- Solid project management skills and effective written, oral, and presentation skills.
- Familiarity with data collection and clinical data management concepts and application in SDTM.
- Strategic thinking - ability to turn strategy into tactical activities.
- Ability to anticipate stakeholder requirements
Preferred Experience and Skills:
- Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC).
- Assuring consistency across protocols and projects.
- Ability and interest to work across cultures and geographies. Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
- Developing and managing a project plan using Microsoft Project or similar package.
- Active in professional societies.
- Process improvement.
- Knowledge of Meta Data Repositories.
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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