
Sr Associate Biostatistical Programming
3 weeks ago
Responsibilities:
- 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(Centre for Observational research).
- 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
- Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents
- Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
- Participate in the recruitment of programming staff
- Actively participate in external professional organizations, conferences and/or meetings
- Provide input to and participate in intra-departmental and CfOR meetings
- Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
- Manage staff performance and oversee staff assignments and utilization
-
- What we expect of you
- We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
-
- Basic Qualifications:
- Master's degree and 1 to 3 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
- Bachelor's degree and 3 to 5 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
-
- Diploma and 7 to 9 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience
Preferred Qualifications:
- Experience in
- SQL, and statistical programming using SAS or R
- Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
- Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
- 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
- Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans
- Project fulfillment, statistical programming, issue escalation, results delivery
- statistical programmingSQL required; SAS or R required; Python preferred
- Motivated to learn how to work with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
Key Competencies
- Hands-on programming role
- Expert statistical programming knowledge using SAS or R
- RequiredSAS or R
- RequiredSQL
- PreferredPython
- Excellent verbal and written communication skills in English
- Ability to have efficient exchanges with colleagues across geographical locations
- Agile project management
- Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
- OMOP common data model
- Drug development life cycle
- statistics and basic epidemiologyIncidence and prevalence
- [Required for Regulatory RWE role]CDISC (SDTM, ADaM)
- Scientific / technical excellence
- Oral and written communication, documentation skills
- Leadership
- Innovation
- Teamwork
- Problem solving
- Attention to detail
- Learning mindset
-
Biostatistical Programming Manager
3 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob Description- Lead and develop technical programming and process improvement initiatives within CfOR- Design data quality enhancements- Represent the programming function and participate in multidisciplinary project team meetings- Project manage all programming activities, according to agreed resource and timeline plans- Ensure all programming activities...
-
Biostatistical Programming Manager
3 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob Description- 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- Project manage all programming activities, according to agreed resource and timeline plans-...
-
Prod Compliance Associate Sr
4 hours ago
Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 12,00,000 per year"Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon."Job Description is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Brand Protection Business Operations team as a Prod Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a...
-
Associate/Sr Associate
3 weeks ago
Hyderabad, Telangana, India Talodyn Networks Private Limited Full timeJob DescriptionPosition Associate/Sr Associate TaxLocation: Hyderabad / GurugramDepartment: TaxReports to: Tax ManagerJob Summary:We are seeking a detail-oriented and experienced U.S. Tax Preparer to join our growing tax team. The ideal candidate will be responsible for the accurate preparation of business tax returns (Forms 1120, 1120S, 1065, etc.) in...
-
Associate - Authorization
1 hour ago
Hyderabad, Telangana, India Newport Medical Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Title: Sr Associate - AuthorizationYears of Experience: 1-3 yearsShift Timings: Night Shift (7:00 PM to 4:00 AM)Mode of operation: Work from the officeMode of Interview: In-PersonLocation: Hyderabad, TelanganaJob DescriptionWe are looking for Associate/Sr. Associate with authorization to join our team. The job requirements are below.Additional...
-
Hyderabad, Telangana, India CPVIA Private Limited Full time ₹ 15,00,000 - ₹ 28,00,000 per yearCompany DescriptionCPVIA Private Limitedis a clinical data analytics solutions company offering statistical programming outsourcing and statistical consulting services. Our mission is to help customers accelerate drug development activities across therapeutic areas with increased quality and optimum cost through our experienced and expert team. We provide...
-
Sr Associate Quality Compliance
6 hours ago
Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per yearCareer CategoryQualityJob DescriptionSr Associate Quality ComplianceRole Name: Sr Associate Quality Compliance – Process ModelerDepartment Name: R&D QualityRole GCF: 4ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and...
-
Sr. Associate IS Voice Engineer
3 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionDescriptionWe are seeking a motivated Sr. Associate IS Voice Engineer to join our team in India. This role involves designing and maintaining voice communication systems, ensuring optimal performance and reliability. Ideal candidates will have a passion for technology and the ability to troubleshoot complex issues in a fast-paced...
-
Regulatory Affairs Sr Associate
1 week ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure...
-
Sr. Business Development Associate 2
4 days ago
Hyderabad, Telangana, India NNIIT Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCompany DescriptionNNIIT is India's best learning platform, providing effective e-learning modules, practice, and test series for students from 6th to 12th class. The platform aims to enhance learning abilities through practice and assessment, offering a comprehensive suite of resources to support students' academic journeys.Role DescriptionThis is a...