Senior Manager, Statistical Programming

Role Summary

The Senior Manager, Statistical Programming leads the development and maintenance of statistical programming functions within a therapeutic area to support clinical studies and regulatory submissions. You will collaborate with the Statistical Programming lead to develop strategies and timelines, manage CROs, oversee programming activities, and provide cross-functional support according to project plans.

Responsibilities

• Participates in statistical programming activities on clinical studies and oversees CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions.
• Reviews and validates SDTM, ADaM analysis datasets and TFLs created by CROs.
• Works collaboratively and communicates effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions.
• Manages creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources.
• Manages 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.
• Participates and manages the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.
• Partners with Statisticians and other members of the clinical study team, performs ad hoc analysis.
• Reviews SAP, DMP, CRF, annotated CRF, table shells and other relevant documents by CROs and provides expert feedback from functional perspective.
• Develops SAS programming infrastructure and programming processes improve data deliverables and ad hoc analyses quality and efficiency.
• Builds and mentors a team of programmers as needed to support Beam clinical trials and development pipelines.

Qualifications

• MS or higher degree in Statistics, Mathematics, or related scientific Discipline.
• At least 10 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 is a plus.

Skills

• Base SAS
• SAS Macros
• SAS/Graph
• SAS/Stat
• SAS/ODS
• SAS/SQL
• R
• R-Shiny (preferred)