Lead the development and validation of statistical programs to produce high-quality deliverables for in-house and outsourced projects, ensuring compliance with company and regulatory requirements.
Support ISS/ISE analyses for NDA submissions.
Assist with project work to ensure timely, high-quality delivery across studies.
Create and review programming plans and specifications for datasets and TLFs. Requires advanced knowledge of CDISC standards, including SDTM and ADaM models, with experience in implementing these models.
Review documents produced by biometric functions, such as SAP, CRFs, data review plans, and data transfer agreements.
Review and validate deliverables produced by CROs, including SDTM, ADaM, and TLFs, and provide solutions to issues raised by CROs.
Review e-submission datasets and data documentation, including aCRFs, reviewer guides, define.xml documents, and programs to ensure all files meet submission requirements.
Develop macros to support study and project activities, improving overall efficiency and capacity of the programming function.
Stay current with ICH guidelines and maintain advanced knowledge of submission requirements and standards.
Support the preparation of clinical study reports, regulatory submissions, annual DSURs, and safety reports for multiple studies.
Effectively communicate within the project team environment, across departments, and with external collaborators.
The Ideal Candidate
Expert-level SAS programmer with experience delivering complex programming assignments and analyses. Proficient in developing original code, including macros, as well as modifying existing code.
Advanced knowledge and extensive hands-on experience with CDISC standards, such as CDASH, SDTM, and ADaM.
Experience in the drug development process and working with CROs.
Experience with FDA/EMEA/CDE filings.
Strong interpersonal and effective communication skills (oral and written).
Thorough attention to detail and consistency.
Education Requirement
Bachelor’s degree or equivalent education, preferably in a computational or biological science, with a minimum of 8 years of directly related experience in a drug development environment.
Or a Master’s degree with a minimum of 6 years of related experience.
