Manager/Senior Manager, Statistical Programming

Position Overview:

Beam is looking for a highly talented and motivated Manager/Senior Manager, Statistical Programming, to join our growing Statistical Programming team in the Biometrics department. The senior manager will be responsible for developing and maintaining statistical programming functions within a therapeutic area to support various clinical studies and submissions to ensure successful execution for Beam’s clinical programs. In this role, you will work with the lead of statistical programming to develop statistical programming strategies and timelines. You will manage CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

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.