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 Analyst / Consultant to join one of our clients in the Medical Affairs 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.
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 6 yrs. of clinical programming (CDISC) experience;
Master’s degree in CS, statistics or related disciplines with 7 yrs. of clinical programming (CDISC) experience.
- Need to have Oncology / Hematology TA experience.
- Working knowledge of SDTM and ADaM data models to develop new endpoints and / or new populations.
- Knowledge of statistical methodologies, such as MMRM, survival analysis, ANOVA / ANCOVA, rates and proportions, confidence intervals, and non-parametric analysis.
- Knowledge of registry databases, RWE, HEOR, claims data, HTA regulatory requirements is a plus.
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