Sr. Manager/AD, Statistical Programmer

• Lead and manage statistical programming activities on clinical studies and oversee CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions
• Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs
• Work collaboratively and communicate effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions
• Manage creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources
• Manage the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R
• Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures
• Partner with Statisticians and other members of the clinical study team, perform ad hoc analysis
• Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs and provide expert feedback from functional perspective
• Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities
• Assist the Head of Statistical Programming to develop and implement programming processes, programming standards and SOPs
• Develop SAS programming infrastructure and programming processes to improve data deliverables and ad hoc analyses quality and efficiency
• Build and mentor a team of programmers as needed to support Beam clinical trials and drug development pipelines

• MS or higher degree in Statistics, Mathematics, or related scientific Discipline
• At least 12 years Pharmaceutical/Biotech programming experience
• Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
• Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies
• NDA or BLA submission experience is required
• Excellent organizational skills and ability to prioritize tasks
• Excellent communication and interpersonal skills
• Experience managing CROs and other data vendors
• Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance

Experience with R-Shiny or Python