CrawlJobs Logo

Safety Statistician, Manager

amgen.com Logo

Amgen

Location Icon

Location:
India , Hyderabad

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. Amgen’s Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Manager to provide statistical expertise in support of safety assessment activities across clinical development programs. In this role, you will contribute to the assessment and interpretation of aggregate safety data across multiple studies and products, working closely with Safety Assessment Teams and cross-functional partners. You will apply sound statistical judgment to support safety evaluation and reporting throughout the clinical trial lifecycle.

Job Responsibility:

  • Provide statistical expertise to support the assessment and interpretation of aggregate safety data across multiple studies and programs
  • Contribute to the development and execution of aggregated safety analysis plans and related safety assessment and reporting activities
  • Perform statistical analyses of safety data, including exploratory analyses, and contribute to the interpretation of results and formulation of conclusions
  • Collaborate with cross-functional partners to provide statistical input into safety assessment discussions and deliverables
  • Support the development and application of statistical methods, tools, and analyses for safety assessment, including data visualizations and advanced analytical approaches where appropriate
  • Apply knowledge of statistical principles, regulatory guidance, and internal standards to ensure quality and consistency of safety analyses
  • Stay current with developments in statistical methodology and analytical innovation relevant to safety assessment
  • Adhere to all Amgen policies and Standard Operating Procedures (SOPs).

Requirements:

  • MSc or PhD in Statistics, Biostatistics, or related field with 8years of Industrial experience
  • Proficient in an analytical application (e.g., R or SAS).

Nice to have:

  • Hands-on experience in statistical design and analysis, and machine learning
  • Clinical trial experience within a pharmaceutical or medical research environment
  • Experience in statistical analyses of safety data in a clinical trials setting
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners
  • Proficiency in developing, or supervising the development of, data visualization tools and analytical applications (e.g., R/Shiny) is highly desirable.
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

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Amgen - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Safety Statistician, Manager

Senior Manager-Safety 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
  • MSc or PhD in Statistics, Biostatistics, or related field
  • Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience
  • Proven ability to apply statistical methods in clinical development
  • Proficient in an analytical application (e.g., R or SAS)
Job Responsibility
Job Responsibility
  • Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide sound statistical guidance for safety assessment
  • Act as an independent statistician, providing objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions and recommendations
  • Provide safety statistics expertise on aggregated safety analysis plans (ASAP) and safety assessment and reporting activities across multiple studies/products
  • Develop, maintain, and set standards for associated controlled process documents, including defining best practices for aggregate safety statistical methodologies, and support the development and application of related training and guidance materials across programs
  • Support innovative projects related to technical enhancements for safety assessment, involving data visualizations, decision-making toolkits, and appropriate advanced analytics, including AI integration
  • Maintain familiarity with Amgen statistical policies, strategies, and regulatory guidance, and stay abreast of developments in statistical methods relevant to safety assessment and reporting
What we offer
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
Read More
Arrow Right

Sr. Manager/AD, Statistical Programmer

Beam is looking for an associate Director/Director of statistical programming to...
Location
Location
United States , Cambridge
Salary
Salary:
155000.00 - 225000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 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
Job Responsibility
Job Responsibility
  • 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
  • Fulltime
Read More
Arrow Right

Senior Manager, Statistical Programming

Beam is looking for a highly talented and motivated Senior Manager, Statistical ...
Location
Location
United States , Cambridge
Salary
Salary:
155000.00 - 190000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
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
Job Responsibility
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
  • Fulltime
Read More
Arrow Right

Manager, Statistical Data Sciences Lead

A highly productive, independent statistical data sciences lead ensuring excelle...
Location
Location
Greece , Thessaloniki Pylaia
Salary
Salary:
Not provided
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or Master’s (preferred) Degree in Statistics, Data Sciences, Biological Sciences, IT, or related field
  • At least 5 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
  • Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data
  • Good understanding of ICH and Regulatory Guidelines including submission requirements and data conformance (e.g., Pinnacle21)
  • Statistical Programming and SAS, R, or Python hands-on experience
  • Familiarity with R packages, Shiny Apps, Markdown reports and other associated data science and data analytics tools and AI/ML highly desired
  • Experience with Real World Evidence and other big data sources and associated standards (e.g.OMOP, JSON, ODHSI ) in support of regulatory filings desired
  • Active participation in relevant industry groups (e.g., PHUSE, CDISC, IHD)
  • Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations
  • Thorough understanding of clinical data and relevant data standards (e.g., CDISC)
Job Responsibility
Job Responsibility
  • Ensuring excellence in the delivery of analysis ready datasets, analysis results, and displays such as tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes
  • Ensuring adherence to high quality statistical data sciences principles, processes and techniques in the production of clinical reports
  • Being the statistical data sciences point of contact at the study level, and supporting at the asset/submission level
  • Delivering through combination of oversight of in-house statistical data scientists / vendors / offshore support as well as through hands on application of statistical data sciences techniques
  • Working with department leadership and project teams to establish strategy, timelines, and resourcing of deliverables for their study(ies)
  • Being accountable for the quality and timely delivery of datasets, analysis results and displays required for their clinical study reports as well as other asset level deliverables
  • Ensuring appropriate documentation across the lifespan of the study for deliverables and verifying proper Trial Master File filings
  • Ensuring planning is in place for all deliverables including consideration of special data types and downstream uses of data
  • Working with statisticians, statistical data science resources and other colleagues to ensure clear specifications for deliverables are in place
  • Being knowledgeable in core safety standards as well as Therapeutic Area standards or Industry data standards for unique data types
What we offer
What we offer
  • Work life harmony
  • Trusting, flexible workplace culture
  • Disability inclusion
  • Equal employment opportunities
  • Fulltime
Read More
Arrow Right

Senior Biostatistician

Job opportunity for a permanent, onsite Senior Biostatistician role in Paris, Fr...
Location
Location
France , Paris
Salary
Salary:
Not provided
ab-science.com Logo
AB SCIENCE
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ph.D. in Statistics with minimum 3 years of relevant pharmaceutical (or CRO) industry work experience or Masters in Statistics or equivalent with minimum 5 relevant pharmaceutical (or CRO) industry work experience
  • Good Knowledge of SAS
  • Good Understanding of CDISC Concepts
  • Good understanding of ICH guidelines
  • Fluent in English
Job Responsibility
Job Responsibility
  • Author the Statistical Sections of Protocol
  • Propose and Review the Study design
  • Calculate the sample size
  • Review the Case Report Form (CRF)
  • Review the Edit Check Document (specifically for critical modules like RECIST 1.1 etc.)
  • Write the randomization specifications and coordinate and finalize all the randomization activities with the IWRS vendor
  • Author Statistical Analysis Plan (interim and final as appropriate)
  • Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS
  • Ensure quality of all the outputs developed
  • Perform the role of validator as appropriate
What we offer
What we offer
  • Permanent position
  • Salary & package to define according skills and experience
  • Fulltime
Read More
Arrow Right
New

Onsite Endoscopic Specialist

At KARL STORZ, we are driven by a mission to enhance global health through innov...
Location
Location
United States , Arlington
Salary
Salary:
Not provided
karlstorz.com Logo
KARL STORZ
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A minimum of high school diploma or equivalent
  • Experience in Sterile Processing, Sales, or other Surgical Technology/Medical role
  • Our successful candidate will have excellent written and spoken English language business communication skills. They will also have demonstrated success working in a collaborative, service-oriented team environment.
  • Effective communicator, collaborative, and effective time management
  • Possess exceptional organizational skills and the ability to multi-task
  • MS Office - proficient user as the role will need to work with Excel spreadsheets and reporting
  • Role requires the completion of a drug screening for safety-sensitive positions
  • Must be able to lift/push/pull up to 25lbs
Job Responsibility
Job Responsibility
  • Face-to-face customer support, including OR, SPD and Biomed
  • Video tower/system set-up and support
  • Inspection, repair, troubleshooting and replacement of KARL STORZ devices
  • Monitoring, reporting, and facilitating repair/ exchange transactions
  • Transporting, cleaning/sterilization and packaging of instruments after use
  • Trouble shoot video and instrument issues in the O.R.
  • Instrument/equipment repair management
What we offer
What we offer
  • Relocation Support
  • Professional Growth & Development
  • Collaborative & Dynamic Work Environment
  • Access to Cutting-Edge Medical Technologies
  • Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too
  • 3 weeks vacation, 11 holidays plus paid sick time
  • Up to 8 weeks of 100% paid company parental leave
  • 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • Fulltime
Read More
Arrow Right
New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Columbus
Salary
Salary:
17.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
July 11, 2026
Flip Icon
Requirements
Requirements
  • Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
  • If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
  • If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
Job Responsibility
Job Responsibility
  • Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
  • Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
  • Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
  • keeping patients healthy by offering immunizations and other services at the register and over the phone
  • and demonstrating compassionate care by solving or escalating patient problems
  • Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
  • Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
  • actively seeking opportunities to expand clinical and technical knowledge needed to better assist patients
  • Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
  • voluntarily traveling to stores in the market to work shifts as needed by the business
What we offer
What we offer
  • dental
  • vision
  • wellness resources
  • employee discounts
  • access to certain voluntary benefits
  • other programs
  • Parttime
Read More
Arrow Right
New

Assistant General Manager

Assistant General Manager, at Boston Pizza, one of Canada’s Best Managed Compani...
Location
Location
Canada , Lac La Biche
Salary
Salary:
22.00 - 30.00 CAD / Hour
bostonpizza.com Logo
Boston Pizza
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 1+ year of casual dining experience
  • Previous leadership or supervisory experience is an asset
  • A positive attitude and strong work ethic
  • Excellent communication and team-building skills
  • Ability to thrive in a fast-paced environment
  • A passion for hospitality and guest service
  • Open availability
Job Responsibility
Job Responsibility
  • Support day-to-day operations
  • Lead and motivate the team
  • Ensure an exceptional guest experience
What we offer
What we offer
  • Competitive pay
  • Medical
  • dental benefits
  • Staff accommodations available
  • Flexible scheduling
  • Room to grow within the company
  • Hands-on management training
  • A supportive, close-knit team environment
  • Fulltime
Read More
Arrow Right