Senior Associate - RWE Regulatory Statistical Programming Job at Amgen (Hyderabad)

Senior Associate - RWE Obesity Statistical Programming

Amgen is seeking a dedicated Senior Statistical Programmer to join our Center fo...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field OR
Bachelor’s degree and 2 years of directly related experience OR
Associate’s degree and/or 4 years of directly related experience OR
High school diploma / GED and 6 years of directly related experience
At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience
Experience in SQL, and statistical programming using SAS and R
Track record establishing analysis standards, QC/QA processes, and controlled change management.
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals).
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials

Job Responsibility

Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage programming activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Participate in the development of departmental policies and controlled documents
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences, and meetings

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

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience
Experience in SQL, and statistical programming using SAS and R
Track record establishing analysis standards, QC/QA processes, and controlled change management
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals)
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy
Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC
Experience with Git-based version control and maintaining analysis documentation

Job Responsibility

Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage programming activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Participate in the development of departmental policies and controlled documents
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences, and meetings

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

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience
Experience in SQL, and statistical programming using SAS and R
Track record establishing analysis standards, QC/QA processes, and controlled change management
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals)
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy
Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC
Experience with Git-based version control and maintaining analysis documentation

Job Responsibility

Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage programming activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Participate in the development of departmental policies and controlled documents
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences, and meetings

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

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

New

Social Worker – Fostering - Family and Friends Team

Are you passionate about working with Family and Friends Carers and improving th...

Location

United Kingdom , Aylesbury

Salary:

40109.00 - 47629.00 GBP / Year

Buckinghamshire Council

Expiration Date

July 20, 2026

Requirements

Social work qualification
Active SWE registration
Completed ASYE
Working knowledge of legislation and guidance which applies to family and friends work
Experience of working in looked after children or with foster carers
Knowledge of research, inquiries and recent studies affecting this sector of service and an ability to monitor its application in practice
Strong written communication skills
Minimum of 2 years post qualifying experience
Experience and competence in working with the courts and providing written and verbal evidence

Job Responsibility

Deliver targeted and specialist social work services in the area of Kinship Care
Clarify eligibility and undertake statutory social work assessments
Promote the safety and well-being of children and young people
Assess and support prospective Family and Friends carers in line with Fostering Regulations and court proceedings
Hold a manageable caseload of SG and Reg24 assessments
Provide carer support
Work within statutory guidelines and fostering regulations
Assist with duty with opportunities to deliver training, run support groups and be involved in the organisation of carer events
Support the development and growth of the service

What we offer

Market premium of £2,750 per annum for Grade 7
Golden Hello payment after one years service (£1,000 for Grade 6, £2,125 for Grade 7)
Competitive salary with a market increment
Annual leave up to 30 days per year
Opportunity to buy further leave
Up to 15 days per year training, learning and development offer
Free parking across all office sites
Relocation packages available
Generous employer pension contribution
Discounts on Cafés, restaurants and shops

Fulltime

New

Spanish Speaking Caregiver

Join Our Team as a Caregiver in Lake Ariel, PA! *Earn Up to $14hr + Extra Cash T...

Location

United States , Lake Ariel

Salary:

14.00 USD / Hour

CareGivers America

Expiration Date

Until further notice

Requirements

Must be willing to work in Lake Ariel
Fluent in English, bilingual English/Spanish preferred
Availability to work Wednesday, Thursday, Saturday, and Sunday 6am-6pm
Reliable transportation required
Must be able to travel up to 25 miles to client locations

Job Responsibility

Bring comfort and companionship to clients in their homes
Help with daily care like bathing, dressing, toileting, and meals
Keep living spaces clean, safe, and welcoming
Offer medication reminders and support healthy routines
Communicate concerns and escalate safety issues as needed
Be a friendly face and a steady presence

What we offer

Paid Orientation
Weekly Pay
Flexible Schedules
Earn up to $375 for referring a friend
Caregiver Rewards Program
Premium Holiday Pay
Paid Time Off + Benefits including medical, dental, vision, and retirement
Free Employee Assistance Program
Discount Perks
Career Growth

New

Early Years Consultant

Join our Early Years Service, where we champion the joy of learning for the youn...

Location

United Kingdom , Aylesbury

Salary:

36317.00 - 37780.00 GBP / Year

Buckinghamshire Council

Expiration Date

July 02, 2026

Requirements

Educated to degree level or minimum three years equivalent experience in a similar managerial role
Excellent knowledge and first-hand experience of planning and delivering the EYFS
Experience of supporting vulnerable children including those with SEND and working with their families
Excellent planning and organisational skills
Excellent interpersonal skills
Proven ability to negotiate, inspire and maintain highly effective working relationships
Skilful communicator with ability to engage and influence customers, partners and stakeholders

Job Responsibility

Support providers to deliver the EYFS
Work with providers to meet the needs of all children including those from vulnerable groups and those with SEND
Ensure providers deliver high quality inclusive education
Offer advice and support to ensure early years practitioners deliver an inclusive Early Years Foundation Stage curriculum and meet the requirements of the SEND Code of Practice 2014 and Equality Act 2010
Provide comprehensive support and advice to providers on safeguarding, child protection and the management of allegations against the workforce, along with sustainability, sufficiency, and finance
Contribute to the work of the Early Years Service, ensuring sufficiency of places
Support the early years sector and childcare sector with high quality training, facilitating networking groups and providing advice and support to a full range of Early Years and Childcare providers

What we offer

Fair and inclusive culture
Health and well-being initiatives including Employee Assistance Programme, Mental Health First Aiders and mindfulness workshops
Unified voice through Employee Representative Group
Ongoing support and opportunity to develop and progress in career
Opportunities to take part in fun activities such as fundraising and social events
Flexible and agile working arrangements
Discounts on various cafes, restaurants, shops
Auto enrolment onto generous Pension Scheme
Opportunity to gain membership to Costco
Discounted gym memberships

Fulltime

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Senior Associate - RWE Regulatory Statistical Programming

Job Description

Job Responsibility

Requirements

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