Job Description
Job Description: We're looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Use statistical programming software to develop datasets and tables, figures, and listings that comply with regulatory standards and support the analysis, reporting, interpretation, and publication of clinical trial data.
Responsibilities: - Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies.
- Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools.
- Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology.
- Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development.
- Develops programming efficiencies (eg, local macros) to ensure efficient programming work.
- Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics.
- Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer's guides).
- Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies.
- Leads and manages statistical programming priorities and task assignments for clinical studies and submissions.
- Tracks and escalates concerns related to changes in scope of services.
- Mentor's junior statistical programmers.
Requirements :
- Bachelor's or master's degree or international equivalent in Biostatistics, Statistics, or programming-related field.
- 5 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferred.
- A high level of SAS programming skills including SQL and macro development.
- Good knowledge and application of CDISC standards for SDTM and ADaM.
- Experience with Pinnacle21 and writing reviewer's guides is a plus.
- Basic understanding of standard statistical methodologies is expected.
- Experience with ophthalmology is preferred.
- Good understanding of statistical programming topics in medical product development.
- Excellent technical and programming logic skills.
- A successful history of cross-functional collaboration.
- Sound knowledge of all relevant regulations and guidelines.
- Excellent verbal and written communication skills.
- Good planning and organizational skills with the ability to adapt and adjust to changing priorities.
- Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment.
- A strong interest in developing expertise in ophthalmology.
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