Job Description :
Were 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 annotated CRFs reviewers 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.
- 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.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.Key Skills
Business Development,Customer Service,Attorney,CISSP,Data Analysis
Employment Type : Full-time
Experience : years
Vacancy : 1