CrawlJobs Logo

Biostatistics Manager

United States 131551.95 - 177982.05 USD / Year · Job Posted June 03, 2026
Apply Position
Job Link Share

Job Description

In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Manager independently leads sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary study teams.

Job Responsibility

  • Providing statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
  • Completing statistical analysis of individual studies/projects, proficient in advanced R programming
  • Publishing applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings
  • Being familiar with statistical policy and strategy at Amgen
  • Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
  • Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
  • Assisting in the review of Amgen Policies, SOPs, and other controlled documents
  • Assisting with study and systems audits conducted by Amgen CQA and external bodies
  • Serving as team member of change / process improvement initiatives

Requirements

  • Doctorate degree
  • Master's degree and 3 years of Statistics/Biostatistics experience
  • Bachelor's degree and 5 years of Statistics/Biostatistics experience
  • Doctorate degree in statistics or biostatistics

What we offer

  • Health and welfare plans for staff and eligible dependents
  • financial plans with opportunities to save towards retirement or other goals
  • work/life balance
  • career development opportunities
  • Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • discretionary annual bonus program
  • stock-based long-term incentives
  • award-winning time-off plans
  • flexible work models

Looking for more opportunities?

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

Similar Jobs for

Biostatistics Manager

8 matching positions

Senior Manager Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
  • Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Job Responsibility
Job Responsibility
  • Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
  • Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
  • Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
  • Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
  • Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
  • Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
  • Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
  • Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
  • Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
  • Provide statistical consultancy, training, and advice within Amgen
What we offer
What we offer
  • Vast opportunities to learn and develop within 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
Read More
Arrow Right

Director of Data Management & Biometrics

This is a senior leadership role, responsible for shaping and delivering the str...
Location
Location
United Kingdom
Salary
Salary:
Not provided
mantellassociates.com Logo
Mantell Associates
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree in Statistics, Biostatistics, Computer Science, Life Sciences, or related discipline
  • MSc/PhD preferred
  • Significant leadership experience in clinical data management and biostatistics within a biopharmaceutical or CRO environment
  • Proven track record of building and managing high?performing biometrics teams through multiple phases of clinical development
  • Deep knowledge of CDISC standards (SDTM, ADaM), regulatory expectations, and EDC/CTMS environments
  • Demonstrated experience with advanced analytics, data standards, and clinical database design
  • Exceptional communicator with the ability to collaborate across functions, present to senior leadership, and engage external partners.
Job Responsibility
Job Responsibility
  • Lead and develop the Data Management & Biometrics function, including Clinical Data Management (CDM), Biostatistics, Statistical Programming, and medical coding standards
  • Own the design and delivery of data strategies that ensure high data quality, integrity and compliance throughout clinical development
  • Oversee development and implementation of data standards, CRF design, data flow plans, and database build/validation strategies
  • Partner with Clinical Operations, Safety, Regulatory, and IT to implement leading?edge technologies (e.g., EDC, eCOA, RTSM, CDISC standards)
  • Drive statistical analysis planning, statistical methods, and interpretation of complex clinical datasets
  • Ensure delivery of high-quality, timely outputs for interim looks, IDMC reporting, regulatory submissions, and final study reports
  • Represent Data Management & Biometrics in leadership forums, influencing cross-functional decision-making and resource prioritisation.
  • Fulltime
Read More
Arrow Right

Program Manager II, Biostatistics and Data Science

Under administrative review, performs management level work directed toward the ...
Location
Location
United States , Winston Salem
Salary
Salary:
33.05 - 49.60 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree and three years of relevant experience or equivalent combination
  • Master's degree in Health Administration, Business Administration or related field preferred
  • Three years' experience in project management, program management development, administration or supervisory experience required
  • Excellent oral and written communication skills
  • Previous supervisory experience
  • Solid interpersonal skills to effectively build relationships with business partners across departments and facilitate work among teams
  • Strong analytical and critical thinking skills
  • Strong PC background in computer spreadsheets systems and presentation packages
  • Skilled problem solver who can work independently
  • Ability to manage special projects, work under pressure, meet deadlines
Job Responsibility
Job Responsibility
  • Manages and oversees the planning, implementation, coordination and evaluation of major projects
  • Assumes major responsibility for coordinating the successful and timely completion of the tasks within projects
  • Manages and/or implements all operational policies and procedures related to the functioning of the program
  • Prepares periodic analyses and reports reflecting progress and trends of on-going projects/programs
  • Tracks, evaluates, and interprets collected financial data
  • Manages the preparation of progress reports and quality control monitoring
  • Participates in the analysis of study data and the writing of sponsor progress and financial reports
  • Assists in the administration of the departmental budget by tracking expenditures and performing other financial tasks
  • Assumes responsibility for the outcome of the program(s)
  • Assists and supervises support personnel
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Opportunity for annual increases based on performance
  • Premium pay such as shift, on call, and more based on a teammate's job
  • Incentive pay for select positions
  • Fulltime
Read More
Arrow Right

Billing Tech Support Specialist

Prompt is revolutionizing healthcare by delivering highly automated and modern s...
Location
Location
Salary
Salary:
24.00 - 28.00 USD / Hour
promptemr.com Logo
Prompt
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3+ years of relevant experience in customer-facing functions such as tech support or similar customer facing experience
  • Medical billing background required- Physical Therapy billing strongly preferred
  • Experience in any function of clinical development or medical billing operations (clinical operations, data management, biostatistics, system management, information management, medical monitoring, RCM follow up, claim review and submission, etc.)
  • Must have a highly analytical mindset and with superior ability to troubleshoot/test use cases and issues in software
  • Proactive, self-motivated and self-directed, with the ability to learn quickly and autonomously
  • Ability to multitask, keep records, prepare reports, and follow specific instructions
  • Proficient in MS Excel
  • Exceptional written and verbal communication skills
  • Eagerness to learn and adopt software
Job Responsibility
Job Responsibility
  • Respond to customer questions and requests regarding RCM and billing software questions via email using our help desk platform to help them find solutions to their inquiries in an accurate and efficient manner
  • Triage tickets, perform escalations to appropriate teams, and provide all necessary details to ensure the teams are equipped to assist the customer
  • Support engineering ticket creation, review and prioritization
  • Develop and maintain a deep understanding of our product offerings to effectively respond to incoming customer inquiries across our single-channel support system
  • Promote customer satisfaction and loyalty by understanding each customer’s unique (and evolving) needs, delivering value, and exceeding expectations
  • Improve and advocate for customer experience by identifying opportunities to enhance our product and service features
What we offer
What we offer
  • Bonus potential with exceptional performance
  • Remote/hybrid environment
  • Potential equity compensation for outstanding performance
  • Flexible PTO
  • Company-wide sponsored lunches
  • Company paid disability and life insurance benefits
  • Company paid family and medical leave
  • Medical, dental, and vision insurance benefits
  • Discounted pet insurance
  • FSA/DCA and commuter benefits
  • Fulltime
Read More
Arrow Right

Vice President, Biostatistics

The Vice President, Biostatistics is a key enterprise leader responsible for set...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD or Master’s degree in Biostatistics, Statistics, or related field
  • 10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs
  • At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups
  • Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions
  • Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams
  • Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred
  • Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness
  • Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences
  • Experience managing departmental budgets, vendor relationships, and technical infrastructure
  • Highly collaborative, with strong interpersonal skills and the ability to build trust across teams
Job Responsibility
Job Responsibility
  • Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture
  • Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio
  • Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making
  • Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success
  • Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings
  • Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning
  • Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies
  • Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation
  • Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making
  • Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
Read More
Arrow Right

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or master’s degree with 25+ years of data management experience
  • 10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
  • Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
  • Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
  • Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
  • Understanding of clinical data standards (CDISC, SDTM, ADaM)
  • Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
  • Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
  • Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams
Job Responsibility
Job Responsibility
  • Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
  • Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
  • Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
  • Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
  • Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
  • Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
  • Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
  • Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
  • Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
  • Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data
Read More
Arrow Right

Biostatistics Senior Manager

The Senior Biostatistics Manager independently leads sophisticated studies and p...
Location
Location
United States
Salary
Salary:
154104.15 - 208493.85 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of Biostatistics experience
  • Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 4 years of Biostatistics experience
  • Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of Biostatistics experience
  • Associate’s degree and 10 years of experience
  • High school diploma / GED and 12 years of experience
Job Responsibility
Job Responsibility
  • Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
  • Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis
  • Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
  • Providing input for clinical publications and regulatory filing documents
  • Leading all aspects of work performed by study statisticians
  • Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations
  • Anticipating and communicating resource and quality challenges that could impact results or timelines
  • Solid understanding of regulatory guidelines in drug development
  • Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies
  • Contributing to process improvements and operational efficiencies
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Director, Clinical Scientist

The Director, Clinical Scientist is a senior, hands-on scientific leader respons...
Location
Location
United States , Waltham
Salary
Salary:
175000.00 - 230000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 8+ years of extensive hands-on experience supporting clinical trials in a clinical development role
  • Demonstrated experience reviewing and interpreting clinical trial data listings
  • Strong understanding of clinical trial conduct and cross-functional trial workflows
  • Proven ability to partner effectively with Clinical Operations
  • Exceptional organizational, prioritization, and execution skills
  • Strong written and verbal communication skills
  • Advanced PowerPoint skills
  • working knowledge of Excel and other commonly used clinical systems/tools
  • Ability to manage multiple studies and deadlines in a fast-paced environment
  • Advanced degree in life sciences discipline (PhD, PharmD, MS, or equivalent)
Job Responsibility
Job Responsibility
  • Support the Medical lead for one or more Phase I–III clinical studies
  • Support studies across the full trial lifecycle, from start-up through database lock and reporting
  • Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs
  • Identify data trends, inconsistencies, and potential issues
  • partner with Data Management, Biostatistics, and Safety to resolve them
  • Act as a close scientific partner to Clinical Operations to deliver on trial execution
  • Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
  • Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
  • Develop and deliver clear, well-structured presentations to study teams and internal leadership
  • Drive execution, follow-through, and accountability across multiple concurrent deliverables
What we offer
What we offer
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • Fulltime
Read More
Arrow Right