Statistician, Research Job at Loyal

Biostatistics Sr Mgr

As a Biostatistics Sr. Manager, you will lead study-level statistical deliverabl...

Location

United States

Salary:

154104.15 - 208493.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Bachelor’s 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

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

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 where possible

Fulltime

Heor Medical Writer

MEDICAL WRITER – CLINICAL CONTENT & HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR...

Location

United States , Whippany

Salary:

30.00 - 40.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

PharmD or advanced scientific degree or bachelor's degree in life sciences, pharmacy, public health, health economics, or related field with relevant experience
1–3+ years of experience in medical writing, medical communications, pharma, consultancy, or related environment
HEOR experience preferred
Strong scientific literacy with the ability to interpret and synthesize clinical, medical, and economic data
Excellent writing and editing skills tailored to both scientific and non-scientific audiences
Knowledge of clinical research processes, publication practices, and regulatory standards
Strong attention to detail, organization, and ability to work independently within cross-functional teams
Proficiency with standard authoring and reference tools (e.g., Microsoft Office, Endnote, Adobe Acrobat)

Job Responsibility

Author and support complex scientific deliverables including abstracts, posters, manuscripts, oral presentations, publication extenders, response documents, and white papers across therapeutic areas
Develop medical information content such as standard response letters, FAQs, and customer-facing materials
Draft, edit, and review HEOR-related outputs including value dossiers, slide decks, economic evidence materials, and submissions
Conduct comprehensive literature searches and systematic or targeted reviews to support clinical and HEOR narratives
Partner with health economists, TA researchers, analysts, and statisticians to accurately interpret and translate data from clinical studies, real-world evidence, cost-effectiveness analyses, and budget impact models
Support preparation and submission of content for peer-reviewed journals and scientific congresses
Ensure adherence to publication standards and best practices (e.g., GPP, ICMJE, ISMPP) throughout the content lifecycle
Ensure all materials comply with client policies and external regulatory and ethical guidelines (e.g., FDA/EMA, AMA style)
Maintain high standards for accuracy, consistency, and scientific integrity across all deliverables
Collaborate cross-functionally with internal creative, editorial, medical, and strategic partners

What we offer

Medical
Dental
Vision
Health Savings Account
Dependent Care FSA
Supplemental coverage
401k plan with company match
Paid time off
Sick time
Paid company holidays

Biostatistics Manager, Centralized Statistical Monitoring (CSM)

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

MSc or PhD in Statistics, Biostatistics, or related field with 8 years of Industrial experience
Proficiency in statistical programming (e.g., R, SAS, or Python) with demonstrated experience applying machine learning and advanced analytical methods in practice
Clinical trial experience within a pharmaceutical or medical research environment
Prior experience serving as a study statistician for clinical trials, with responsibility for study-level statistical analysis and reporting
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Demonstrable strategic thinking skills, originality, and creativity
Writing skills with samples of technical writing (papers, reports, or project descriptions)
Self-directed, and well organized

Job Responsibility

Provide statistical and data science expertise to support CSM activities across multiple studies and therapeutic areas
Develop and enhance statistical, machine learning, and AI-guided methodologies, to strengthen CSM signal detection and site-level risk assessment
Perform detailed statistical review and quality control of CSM outputs, signals, and study-level metrics to ensure accuracy, consistency, and appropriate interpretation prior to stakeholder communication
Collaborate with cross-functional partners (e.g., Clinical, Operations, Data Management, RBQM, Quality, Digital/Technology teams) to translate critical-to-quality (CTQ) factors into analytically robust and scalable monitoring solutions
Contribute to validation, documentation, and controlled deployment of analytical methodologies and tools within regulated environments, ensuring reproducibility and adherence to internal standards
Develop clear visualizations, dashboards, and analytical applications to enhance transparency and facilitate interpretation of monitoring outputs
Stay current with evolving developments in data science, machine learning, and AI relevant to clinical trial monitoring
Adhere to all Amgen policies and Standard Operating Procedures (SOPs)

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Associate Director, Quality Control Technical Services

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy
Extensive hands-on experience with ex vivo autologous cell therapies, including CD34+ cell-based products, across late-stage development, validation, and/or commercial readiness
Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS-based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred
Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late-stage and commercial products
Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase-appropriate and inspection-ready manner
Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post-approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions
Demonstrated ability to lead and influence cross-functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast-paced, matrixed environment
Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners
Documented success in driving complex, program-critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams
Highly developed organizational, analytical, and problem-solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies

Job Responsibility

Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization
Define and execute the QC testing, method strategy, and technical execution to enable next-generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer
Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase-appropriate, and inspection-ready execution
Establish and maintain analytical control strategies by tracking and trending in-process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products
Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs
Lead analytical method lifecycle management for late-stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement
Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control laboratory, strengthening internal capabilities and supporting long-term commercial supply
Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness
Partner with Regulatory Affairs-CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries
Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post-approval requirements, and method introduction or change strategies

Fulltime

Sr. Manager, Data Science

The Senior Manager, Data Science is responsible for the design and validation of...

Location

Canada , North York

Salary:

120000.00 - 150000.00 CAD / Year

Randstad

Expiration Date

July 12, 2026

Requirements

Master’s or Doctorate degree in Statistics or Data Science or related field with strong statistical and computational skills
Accredited Statistician or Advanced Data Science certifications preferred
5 years or more in a similar role or a combination of experience and educational background
Expertise in theoretical and applied statistics, from sample design to modeling and forecasting
Solid knowledge of advanced analytics, data integration, natural language processing and AI-driven methodologies
Familiarity with Large Language Models and synthetic population frameworks considered an asset
Advanced knowledge of statistical packages and data science programming (e.g. Python, R)
Advanced analytical and critical thinking skills
Strong leadership and people management skills

Job Responsibility

Be responsible for the quality and statistical research rigor of data products including developing and reviewing weighting, fusion, calibration, attribution and other statistical processes as well as the accuracy and reliability of data outputs
Manage the Data Science team in order to provide recommendations for the use of statistical, Data Science and AI methodologies, the continuous improvement of current analytical data processes and procedures, and the expansion of value added to data products
Oversee the application and review of data mining, data integration and hybrid methodologies
Assess the integrity of statistical and machine learning models developed internally or built externally by business partners, guaranteeing the use of rigorous research statistical and data science standards
Develop and support alternative or new approaches including hybrid methodologies for the mining, management, production and usability of new data outputs, leveraging both data and information from a variety of internal and external sources
Produce, supervise and vet reports and recommendations based on data modelling, advanced analytics and simulations with business impact on our clients
Support automation projects throughout the organization by implementing solutions that drive efficiency
Work closely with Data Science partners, as well as internal Product, Technology and Operations staff

What we offer

Benefits package, group savings and retirement program
Health and Dental employer paid premiums
Hybrid Work: on-site office in Toronto and work from home as required per the role
4 weeks paid vacation
Education Reimbursement: funding up to $1000 per year
Continuous learning and development via Percipio
MentorMe program
Leadership Training offerings
Perkopolis: exclusive discounts on products and services

Fulltime

Principal Statistician - Medical & Market Access Statistics

GSK Oncology has a commitment to the discovery and development of new oncology t...

Location

United Kingdom; United States , Stevenage; London; Collegeville; Waltham

Salary:

126225.00 - 210375.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

MSc or PhD in Statistics, Mathematics or equivalent with relevant experience in clinical research, pharmaceutical, CRO, or academic settings
Proven statistical contributions and accomplishments in late-phase clinical drug development
Good statistics programming skills and experience in R and/or python
Self-motivated with strong time management skills to manage multiple tasks effectively across projects
Excellent interpersonal and communication skills, including the ability to explain methods to senior stakeholders, and ability to build and maintain strong working relationships
Experience successfully influencing across functions and organizational levels

Job Responsibility

Provide statistical input for the design, analysis, reporting, and interpretation of non-registrational studies
Shape clinical development plans, HTA strategies, and commercial approaches
Build and maintain strategic relationships with internal and external stakeholders to address business needs
Develop and implement novel statistical methods to tackle complex challenges
Address market access and reimbursement challenges from regional agencies by collaborating with cross-functional teams
Work with Health Outcomes and Market Access teams to analyze and interpret clinical trials and real-world data, while expanding expertise beyond traditional statistics

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Pension plan membership
Shares and savings programme

Fulltime

Senior Manager Biostatistics (Study Lead Statistician)

How might you defy imagination? If you feel like you're part of something bigger...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master's 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
Bachelor'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

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

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

Fulltime

Data Manager Project Leader

We are currently seeking a Program Manager, Clinical Data Science to join our di...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in data science, statistics, clinical research, or a related field
Advanced degree and/or relevant certifications are preferred
Extensive experience in program management within the clinical data science or related domain
Strong background in data science methodologies, statistical analysis, and clinical research, with a track record of successfully managing complex data-driven projects
Exceptional leadership skills with experience managing cross-functional teams and collaborating with various departments to achieve program objectives
Proficiency in project management tools and techniques, with experience in risk management, budgeting, and resource planning
Excellent communication and interpersonal skills, with the ability to convey complex data insights clearly and build effective relationships with stakeholders at all levels

Job Responsibility

Managing the end-to-end execution of clinical data science programs, including planning, resource allocation, and delivery of data science projects within scope, time, and budget constraints
Coordinating with data scientists, statisticians, clinical researchers, and other stakeholders to ensure alignment on project objectives, data requirements, and analytical approaches
Developing and maintaining program plans, timelines, and budgets, and monitoring progress to ensure timely and successful completion of data science initiatives
Providing strategic oversight and guidance on data science methodologies, ensuring that analyses are rigorous, valid, and aligned with clinical and regulatory standards
Communicating program status, insights, and outcomes to stakeholders, including executive leadership, and addressing any issues or risks that may impact program success

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

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Statistician, Research

Job Description

Job Responsibility

Requirements

What we offer

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