Bachelor's or master's degree in Biostatistics, Statistics, or related field.
5+ years of experience in clinical trial support for regulatory submissions, preferably as a lead.
High-level SAS programming skills including SQL and macro development.
Good knowledge and application of CDISC standards (SDTM and ADaM).
Experience with Pinnacle21 and writing reviewer's guides is advantageous.
Basic understanding of statistical methodologies is expected.
Strong cross-functional collaboration experience.
Responsibilities
Ensure statistical deliverables and study datasets are programmed and validated according to regulatory standards.
Assess study datasets and resolve CDISC deviations using quality tools like Pinnacle21.
Maintain awareness of industry trends in statistical programming and ophthalmology.
Provide technical consultation to stakeholders on statistical programming services.
Develop programming efficiencies, such as local and global macros, for streamlined work.
Support innovation and process improvements within Biostatistics.
Create specification documents and supporting materials for datasets.
Benefits
Opportunity for continuous professional development and training in a specialized field.
Supportive work environment fostering collaboration across teams.
Access to innovative tools and methods in biostatistics and data management.
Full Job Description
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
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
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
