Senior Manager, Statistical Programming jobs in United States
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Beam Therapeutics · 2 weeks ago

Senior Manager, Statistical Programming

Beam Therapeutics is a biotechnology company focused on precision genetic medicines. They are seeking a Senior Manager, Statistical Programming to lead statistical programming functions for clinical studies and submissions, ensuring successful execution of clinical programs.

BiotechnologyGeneticsMedicalTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Advanced SAS programmingStatistical backgroundCDISC knowledgeNDA/BLA submission experienceExperience managing CROsICH guidelinesR-ShinyOrganizational skillsCommunication skillsInterpersonal skills

Required

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

Preferred

Experience with R-Shiny is a plus

Company

Beam Therapeutics

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Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.

H1B Sponsorship

Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)

Funding

Current Stage
Public Company
Total Funding
$1.19B
2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M

Leadership Team

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John Evans
CEO
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Christine Bellon
Chief Legal Officer
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Company data provided by crunchbase