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geron corporation
programming manager
Posted
1 week 5 days ago

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Job Description

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Position Summary Programming Manager will be part of the Statistical Programming group. The Manager will be responsible for implementing clinical data standards and statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. The individual will be responsible for the application of clinical data standards, leading/supporting the creation of SDTM (Study Data Tabulation Model) datasets across studies and supporting analyses as needed. This position reports to Director, Statistical Programming, working closely with Data Management, Biostatistics, Clinical Operations, Regulatory, and other related disciplines, as well as CROs. This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. Primary Responsibilities * Provide technical expertise and documentation for SDTM data standardization activities across multiple studies. * Use the knowledge of clinical data management standards and systems to map data elements from raw clinical trials data files to CDISC and internal standard data models and controlled terminologies to support construction of clinical analysis datasets. * Act as the SDTM subject matter expert, supporting all SDTM programming and regulatory submission-related activities with vendors and internal team. * Develops unambiguous and robust programming specifications (e.g. SDTM specifications). * Understand and convert analytical data requirements to data collection domain/variables following CDISC and internal data models and controlled terminologies. * Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards. * Communicates proactively and effectively around issues and risks and contributes to its remediation. * Identifies, leads, and supports opportunities to enhance processes and technology. Experience & Competencies * Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences, Master's degree preferred. * At least 5 years programming experience in industry including support of SDTM development for electronic submissions. * Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data. * Broad expertise in clinical and statistical programming and in developing computing strategies. * In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases. * Demonstrated proficiency in using SAS to produce SDTMs, analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) * Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) * Demonstrated ability to work in a team environment with clinical team members. * Experience with R and/or Python, preferred * Experience in Oncology trials, preferred Benefit Statement: All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, a 401(k)-retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life events. Salary Statement: Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations. General Salary Range: $125,000 to $135,000

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