Safety Statistician, Manager Job at Amgen (Hyderabad)

Senior Manager-Safety Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

Sr. Manager/AD, Statistical Programmer

Beam is looking for an associate Director/Director of statistical programming to...

Location

United States , Cambridge

Salary:

155000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

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

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

Manager, Statistical Data Sciences Lead

A highly productive, independent statistical data sciences lead ensuring excelle...

Location

Greece , Thessaloniki Pylaia

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

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

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

Work life harmony
Trusting, flexible workplace culture
Disability inclusion
Equal employment opportunities

Fulltime

Senior Biostatistician

Job opportunity for a permanent, onsite Senior Biostatistician role in Paris, Fr...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

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

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

Permanent position
Salary & package to define according skills and experience

Fulltime

Senior Manager, Statistical Programming

Beam is looking for a highly talented and motivated Senior Manager, Statistical ...

Location

United States , Cambridge

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

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

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

Job Maps Management Specialist

Location

Poland , Wrocław

Salary:

Not provided

AmRest

Expiration Date

Until further notice

Requirements

Minimum 1 years’ experience in a similar position
Communicative level of English
Excellent knowledge of MS Office
Diligence and attention to details
Ability to plan and manage work
Experience in working in an international environment.

Job Responsibility

Manage and maintain global Job Descriptions and Job Maps, ensuring accuracy, consistency, and alignment with the organization’s structure and business model
Apply and support global job mapping standards and methodology across brands, functions, and countries
Act as a partner and subject‑matter expert for HR teams and business stakeholders regarding Job Maps, role scopes, and job titles
Ensure alignment between Job Maps and the Global Job Titles Matrix, providing guidance on correct job title usage
Monitor the quality, completeness, and adoption of Job Maps
Maintain Job Descriptions and position data in HR systems (e.g. SyncPeople), ensuring data accuracy and regular updates
Support job architecture projects and rollouts and contribute to related communication and training materials.

What we offer

Stable employment under an employment contract in a global organization
Annual bonus - up to 10% of gross annual earnings
Work in a hybrid / remote model
Personalized benefits package: discounts to our cafes and restaurants, private medical care, Multisport card and much more
A friendly atmosphere in an international and fast growing Team.

Fulltime

Front Desk Coordinator

Front Desk Coordinator Are you an organized detail oriented with excellent commu...

Location

United States of America , Saint Louis

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Previous experience in a receptionist or administrative support role preferred
Strong communication and customer service skills
Ability to multitask and prioritize in a fast-paced environment
Proficiency with office technology and Microsoft Office Suite

Job Responsibility

Greet visitors, clients, and team members with professionalism and warmth
Answer and route incoming calls
manage messages and inquiries
Maintain reception area and conference room schedules
Handle mail, deliveries, and office supply inventory
Assist with administrative tasks, data entry, and special projects
Collaborate with staff to support internal communication and workflow

What we offer

Competitive compensation and benefits
Collaborative, welcoming work culture
Opportunities for skill development and career growth
Exposure to multiple departments and business operations
Medical, vision, dental, and life and disability insurance
401(k) plan

Fulltime

Sales and Customer Service Representative

A growing mid-size organization is seeking a results-driven Sales & Customer Ser...

Location

United States of America , Morristown

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

1–3+ years of experience in sales, inside sales, or a sales-driven customer service role
Proven ability to meet or exceed sales targets
Strong communication and negotiation skills
Highly motivated, competitive, and results-oriented
Proficiency in Microsoft Office
CRM experience (Salesforce, HubSpot, etc.) preferred
Ability to multitask in a fast-paced, team-oriented environment

Job Responsibility

Proactively engage with prospective and existing customers to generate sales and meet revenue targets
Identify upsell and cross-sell opportunities to grow account value
Manage the full sales cycle, from initial outreach through order placement and follow-up
Build and maintain strong client relationships to drive repeat business and long-term partnerships
Handle customer inquiries, resolve issues, and ensure a positive customer experience
Process orders, prepare quotes, and provide product or service recommendations
Maintain accurate records of sales activity, pipeline, and client interactions within CRM systems
Track performance against sales goals and report on activity and results

What we offer

medical
vision
dental
life and disability insurance
401(k) plan
free online training

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Safety Statistician, Manager

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