Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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, Sponsors, and SOPs.
- 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) as detailed in SOPs.
- 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.
- Mentors' 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.
- A strong interest in developing expertise in ophthalmology.
- 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.