Sr. Statistical Programmer
Sr. Statistical Programmer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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 annotated CRFs reviewers 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:
- Bachelors or masters 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 reviewers 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.
Employment Type
Full-time
