Principal Statistical Programmer

As Principal Statistical Programmer, you will lead programming support for oncology development program in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, validate and document SAS® programs in accordance with company, industry, and regulatory requirements; you will play a key role in developing, implementing and evaluating statistical programming standards and processes.

Day-to-Day Duties:

• Manage and lead all programming activities in a drug development program; contribute to the development of timelines and resource plan
• Identify & resolve systemic resourcing, process, or quality issues that could impact individual study deliverables
• Contributes to the tracking of metrics and performance measures both internally and externally
• Create/review programming plan, specifications for datasets and TLFs. advanced level of understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models.
• Develop and validate SAS® programs to produce high quality deliverables for in-house projects in compliance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures.
• Develops and test SAS Software programs to complete complex analyses and data cleaning with no supervision
• Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/implement solutions to identified issues; ensure datasets are in compliance with submission standards
• Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
• Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements.
• Review and provide input on documents produced by other Data Science functions such as: statistical analysis plans; TFL shells; data management plans; data transfer plans and case report forms.
• Familiar with ICH guidelines, advanced knowledge of submission requirements and standards, ensure that statistical programming deliverables are in compliance with regulatory requirements, industry and company standards.
• Having expert level of SAS programming expertise, develop macro tools to improve efficiency at study and project levels for efficiency.
• Lead the development, implementation and continuous improvement of programming processes and standard
• Participate programming vendor evaluation and selection
• Effectively communicate in a project team environment, within department, among functional groups and external collaborators
• Perform other programming duties as assigned

Requirements:

• Minimum of BS required in Computer Science, Statistics, Life Sciences or other related field
• BS with 8+ years or MS with 6+ years of SAS programming experience in drug development in CRO or pharma/biotech company
• Good written and verbal communication skills.
• Oncology and submission experience preferred

EOE