Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com). Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for five disease areas - osteoarthritis, androgenetic alopecia, oncology, degenerative disc disease and idiopathic pulmonary fibrosis - and has a broad pipeline targeting areas of significant unmet medical need.
Job Description and Responsibilities:
As part of Samumed’s Programming group, this position will lead programming support for multiple studies in multiple stages of clinical development. This position will interact with Biostatistics, Clinical Data Management, Medical Writing, Clinical Operations, and Regulatory to design, write, and validate SAS programs in accordance with company, industry, and regulatory requirements.
Duties and responsibilities include the following:
• Manage and lead programming activities in a drug development program; contribute to the development of timelines and resource planning
• Create / review specifications for CDISC SDTM modelled tabulation data sets (TD), CDISC ADaM modelled analysis data sets (AD) and tables, figures, and listings (TFL)
• Develop and validate SAS programs to produce high quality deliverables for in-house projects in compliance with company and regulatory requirements. The deliverables include TD, AD, define.xml, and TFL.
• Perform conformance checking of CDISC modelled TD, AD, and define.xml using Pinnacle 21’s OpenCDISC Community tool and applicable regulatory agency data standards requirements to ensure data sets are in compliance with submission standards
• Review and provide input on documents produced by other functional groups, including: statistical analysis plans (SAP), data presentation plans (DPP), data management plans (DMP), data transfer agreements (DTA), Medidata Rave study design specifications (SDS), and case report forms (CRF)
• Apply ICH guidelines and submission standards to ensure that programming deliverables are in compliance with regulatory requirements as well as industry and company standards
• Develop global macro tools to improve efficiency for common programming tasks
• Lead the development and continuous improvement of programming processes and keep abreast of current data standards and data package submission requirements
• Train personnel on the CDSIC SDTM and provide implementation guidance
• Effectively communicate in a project team environment, within department, and among functional groups
• Perform other programming duties as assigned
• Minimum of BS required in Mathematics, Statistics, Life Sciences or other related field
• BS with 6+ years or MS with 4+ years of SAS programming experience in clinical research
• In-depth knowledge of applicable clinical research regulatory requirements (i.e., GCP and ICH)
• Expertise in CDISC SDTM implementation (4+ years); CDISC ADaM implementation experience a plus
• Excellent written and verbal communication skills
• Excellent organizational skills as demonstrated by effectively handling multiple tasks and projects