CrawlJobs Logo
Beam Therapeutics Logo Beam Therapeutics · IT - Software Development

Senior Manager, Statistical Programming

United States, Cambridge 155000.00 - 190000.00 USD / Year · Job Posted December 24, 2025
Apply Position
Job Link Share

Job Description

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.

Job Responsibility

  • 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

Requirements

  • 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

Nice to have

Experience with R-Shiny is a plus

Beam Therapeutics - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Manager, Statistical Programming

8 matching positions

Biostatistical Programming Senior Manager

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States
Salary
Salary:
157896.85 - 213625.15 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years Statistical Programming experience
  • Master’s degree and 6 years Statistical Programming experience
  • Bachelor’s degree and 8 years Statistical Programming experience
  • Associate’s degree and 10 years Statistical Programming experience
  • High school diploma and 12 years Statistical Programming experience
Job Responsibility
Job Responsibility
  • Maintain and develop re-usable software utilities for GBS and GSP
  • Provide technical leadership and guidance for programming teams
  • Oversee FSP programming team
  • Partner with IS to maintain and enhance GSP systems
  • Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
  • Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data
  • Adhere to functional standards, processes and methods across all projects
  • Create, maintain, and review key SDLC documents -Requirements, Operational Qualification, Installation Qualification, and Design documents
  • Create, maintain, and review end-user documentation (e.g., user guides, training materials)
  • Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Biostatistical Programming Senior Manager

In this vital role you will provide operational and technical leadership for Rea...
Location
Location
United Kingdom , Uxbridge; Cambridge
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree educated
  • Relevant statistical programming experience within life sciences, clinical development, or observational research
  • Experience leading people, projects, programs, or resource allocation activities within a programming environment
  • Experience working with real-world healthcare data, including healthcare claims and EHR databases
  • Strong programming expertise in SAS and SQL
  • Knowledge of observational research methods, drug development, and epidemiology principles
  • Strong communication, collaboration, and stakeholder management skills
  • Demonstrated leadership, problem-solving ability, innovation, and attention to detail
  • Experience with R and/or Python is preferred but not mandatory
Job Responsibility
Job Responsibility
  • Provide operational and technical leadership for Real-World Evidence (RWE) biostatistical programming within the Centre for Observational Research (CfOR)
  • Lead and develop programming teams, partnering closely with epidemiologists and cross-functional stakeholders across multiple time zones to deliver high-quality RWE from large healthcare data sources, including electronic health records (EHR) and healthcare claims databases
  • Oversee project delivery, resource planning, technical excellence, and compliance with departmental standards and processes to support regulatory, publication, and enterprise objectives
  • Leading and developing programming staff, including mentoring, workload planning, and performance oversight
  • Partnering with epidemiologists, RWE scientists, and programming leads to generate robust real-world evidence from healthcare data assets
  • Providing technical leadership and guidance in statistical programming methods, standards, and best practices
  • Managing programming activities, timelines, deliverables, and resource allocation across multiple projects and priorities
  • Ensuring programming activities comply with departmental standards, SOPs, quality expectations, and regulatory requirements
  • Authoring, reviewing, and approving programming plans, analysis dataset specifications, macros, and other key study documentation
  • Contributing to the development, validation, and execution of analysis datasets and outputs supporting regulatory submissions, publications, and scientific communications
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Biostatistical Programming Senior Manager

In this vital role you will be responsible for developing and leading teams in t...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • Master’s degree and 8 to 10 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • Bachelor’s degree and 10 to 14 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • Diploma and 14 to 18 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • At least eight (8) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a statistical programming team working with real-world healthcare data (RWD)
  • Experience leading a statistical programming team within RWE
  • RWE generation in pharmaceutical or related research industries, or statistical programming for clinical trials
  • Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
  • Department or multi-team management
Job Responsibility
Job Responsibility
  • Provide technical solutions to programming problems within the Centre for Observational Research (CfOR)
  • Lead and develop technical programming and process improvement initiatives within CfOR
  • Represent the programming function and participate in multidisciplinary project team meetings
  • Project manage programming activities, according to agreed resource and timeline plans
  • Ensure programming activities adhere to departmental standards and SOPs
  • Write and/or review and approve programming plans
  • Write and/or review and approve analysis dataset specifications
  • Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
  • Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
  • Write, test, validate and execute department-, product- and protocol-level macros and utilities
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Read More
Arrow Right

Senior Manager, Biostatistical Programming

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment
  • Strong technical, communication, and leadership skills
  • Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
  • Experience developing a successful offshore statistical programming team
  • Flexibility and desire to work across different time-zones
  • Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.)
  • Prior regulatory submission experience for drug approval
  • Thorough understanding and experience with data quality and compliance checks
  • Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners
Job Responsibility
Job Responsibility
  • Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team
  • Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally
  • Plan and monitor progress of projects and address issues accordingly
  • Provide GSP product level input to developing and managing resource plans and budgets for GSP
  • Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
  • Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
  • Assist in study and system audits and inspections by internal and external bodies
  • Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
  • Provide hands-on support to the assigned product areas as required
  • Provide coaching and mentoring to local programming staff
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Senior Manager, Biostatistical Programming

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment
  • Strong technical, communication, and leadership skills
  • Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
  • Experience developing a successful offshore statistical programming team
  • Flexibility and desire to work across different time-zones
  • Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.)
  • Prior regulatory submission experience for drug approval
  • Thorough understanding and experience with data quality and compliance checks
  • Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners
Job Responsibility
Job Responsibility
  • Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team
  • Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally
  • Plan and monitor progress of projects and address issues accordingly
  • Provide GSP product level input to developing and managing resource plans and budgets for GSP
  • Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
  • Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
  • Assist in study and system audits and inspections by internal and external bodies
  • Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
  • Provide hands-on support to the assigned product areas as required
  • Provide coaching and mentoring to local programming staff
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Senior Director, Statistical Programming

Lead the statistical programming team, overseeing resource management, project d...
Location
Location
Italy , Milano
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 15+ years of experience in statistical programming within Biotechnology, Pharmaceutical, or CRO environments
  • 5+ years in a leadership role
  • Prior experience managing a statistical programming team
  • Expert in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS, and R
  • Deep understanding of ICH guidelines, CDISC standards, 21 CFR Part 11, FDA and EMA regulations, and global drug development processes
  • Experience with eCTD NDA submissions
  • Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field
  • Master’s preferred
  • Exceptional organizational, multi-tasking, and problem-solving skills
  • Strong interpersonal and communication skills
Job Responsibility
Job Responsibility
  • Lead and manage the statistical programming team to ensure optimal use of resources, adherence to timelines, and achievement of departmental and organizational goals
  • Ensure infrastructure, staffing, and training plans support project completion on time and within budget
  • Provide accurate forecasting for annual budgets and manage financial performance throughout the year
  • Mentor, coach, and develop team members to maximize performance and career growth
  • Maintain complete and auditable documentation of all programming activities and oversee CRO/vendor deliverables
  • Provide statistical programming support for regulatory submissions, exploratory analyses, and ad-hoc requests
  • Manage development, testing, and documentation of global utility programs and tools per standards and validation procedures
  • Participate in creation, implementation, and maintenance of departmental procedures and standards
  • Facilitate communication and collaboration across cross-functional teams and ensure alignment with legal, compliance, and regulatory requirements
  • Champion the “ONE Team” approach to foster collaboration and focus on patient and customer priorities
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Senior Associate - RWE Regulatory Statistical Programming

Amgen is seeking a dedicated Biostatistical Senior Programmer to join our Center...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • At least four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
  • Proficiency in SQL programming and SAS or R programming is required
  • Ability to work effectively within a large, globally distributed team
Job Responsibility
Job Responsibility
  • Support a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and projects
  • Coordinate with functional leads to prioritize workflow
  • Provide technical solutions to programming problems within CfOR
  • Ensure the analysis and presentation of biomedical data is accurate and complete
  • Adhere to Amgen policies, SOPs and other controlled documents
  • Write, test, and validate programs in SAS, Databricks, or R to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications, and other internal and external communications
  • Complete programming activities, according to agreed resource and timeline plans
  • Review key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
  • Write and/or review programming plans and analysis dataset specifications
  • Represent the programming function and participate in multidisciplinary project team meetings
Read More
Arrow Right

Senior Associate - RWE Obesity Statistical Programming

Amgen is seeking a dedicated Senior Statistical Programmer to join our Center fo...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • At least four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
  • Experience in SQL, and statistical programming using SAS or R
Job Responsibility
Job Responsibility
  • Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
  • Provide technical solutions to programming problems within CfOR
  • Lead and develop technical programming and process improvement initiatives within CfOR
  • Represent the programming function and participate in multidisciplinary project team meetings
  • Manage all programming activities, according to agreed resource and timeline plans
  • Ensure all programming activities on the project adhere to departmental standards
  • Write and/or review and approve all programming plans
  • Write and/or review and approve analysis dataset specifications
  • Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
  • Write, test, validate and execute department-, product- and protocol-level macros and utilities
Read More
Arrow Right