Position Overview:

Beam is looking for a Senior Manager/Associate Director of statistical programming to join our growing Statistical Programming team in the Biometrics department. This individual 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 head of statistical programming and the head of biometrics to develop statistical programming strategies, SAS programming infrastructure as well as department standards, applications and processes. 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:

• 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.

Qualifications:

• 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 is a plus.

Position Overview:

Reporting to the Senior Director, Clinical Data Management, the Associate Director / Director, Clinical Data Management will serve as the dedicated data management lead for our Liver franchise. Initially supporting a single study within the program, this individual will grow with the franchise as it expands to include additional studies within the same program and, ultimately, other programs across the franchise portfolio.

This role offers a unique blend of hands-on study oversight and strategic leadership, making it an ideal opportunity for a candidate who thrives at the intersection of execution and innovation, in a fast‑paced biotech environment where clarity, quality, and collaboration are critical.

This is a highly visible role working cross‑functionally with Clinical Development, Biostatistics, Statistical Programming, Regulatory, Quality, and external partners to ensure data integrity, inspection readiness, and timely delivery of data supporting key development and regulatory milestones.

Primary Responsibilities:

Program & Study Ownership

• Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area.
• Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials.
• Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions.
• Proactively identify data risks, trends, and operational dependencies; communicate issues early with clear, solution-oriented recommendations.

CRO & Vendor Oversight

• Serve as the primary data management contact for CROs and third-party data vendors.
• Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations.
• Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies in partnership with the Senior Director of Data Management.

Data Standards, Systems & Process Contribution

• Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models as the organization scales its clinical portfolio.
• Provide hands-on leadership for:
• CRF design and cross functional review
• Edit check specifications and user acceptance testing
• Data Management Plans and CRF Completion Guidelines
• External data transfer specifications
• Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml.

Inspection Readiness

• Support inspection readiness activities across assigned programs, ensuring documentation and data traceability meet regulatory expectations.
• Serve as a key data management participant during audits and inspections, in coordination with the Senior Director and Quality.
• Ensure data management deliverables remain inspection ready throughout the study lifecycle.

Cross-Functional Partnership

• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Regulatory, and Quality.
• Communicate complex data issues clearly and effectively to stakeholders with varying technical backgrounds.
• Build trust as a pragmatic, detail-oriented partner who balances scientific rigor with efficient execution.

Required Qualifications:

• BS or MS degree in a scientific or health-related field.
• 10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments.
• Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies.
• Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform).
• Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations.
• Proven experience overseeing CROs and external data vendors.
• Experience developing reports using J-Review and/or other CDM reporting tools.
• Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable.
• Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies.
• Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization.

Preferred Qualifications:

• Experience and knowledge of gene/cell therapy and/or rare disease.
• Prior experience supporting registrational or pre registrational programs.

Position Overview:

Beam is looking for a highly talented and motivated 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.
• #LI-Hybrid