Indero

Indero, formerly known as Innovaderm, is a Canadian research institute specializing in dermatology and rheumatology, positioning itself as a clinical trial delivery partner for imm

Senior Statistical Programmer

Location

Argentina

Posted

64 days ago

Salary

0

Seniority

Senior

Job Description

Senior Statistical Programmer

Indero

Role Description The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate in internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs. The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’s standard operating procedures (SOPs) and processes. More specifically, the Senior Statistical Programmer must: - Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. - Act as a Lead Statistical Programmer on multiple single studies. - Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. - Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells. - Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. - Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). - Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Innovaderm and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. - Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs. - Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables. - Participate in internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/improvement/validation of standard macros, templates, and programming standards and processes. - Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. - May also mentor more junior Statistical Programmers. - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Qualifications - Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset. - At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 4 years of Statistical Programming and 1 year acting as a Lead Statistical Programmer. - Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. - Excellent working knowledge of SAS; SAS certification an asset. - Knowledge of XML programming an asset. - Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. - Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. - Very organized and detail-oriented, with effective project planning and time management skills. - Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. - Must be able to work independently and as part of a team. - Strong verbal and written communication skills in English; French an asset. Benefits - Permanent full-time position - Flexible schedule - Home-based position - Ongoing learning and development Company Description At Indero, formerly Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Indero, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formerly Innovaderm continues to grow and expand in North America and Europe. Indero, formerly Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formerly Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero, formerly Innovaderm only accepts applicants who can legally work in Argentina.

Related Job Pages

More Software Engineer Jobs

Statistical Programmer

Indero

Indero, formerly known as Innovaderm, is a Canadian research institute specializing in dermatology and rheumatology, positioning itself as a clinical trial delivery partner for imm

Role Description The Statistical Programmer will be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), and Tables, Listings, and Figures (TLFs) required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Statistical Programmer will also support Data Management (DM) with data cleaning activities, use global SAS macros and participate in internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs and ADaMs. The Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’s standard operating procedures (SOPs) and processes. More specifically, the Statistical Programmer must: - Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. - Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. - Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. - Develop/maintain/validate (as applicable) annotated Case Report Forms (aCRFs) according to protocol, electronic Case Report Forms (eCRF), and Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). - Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Develop/maintain/validate (as applicable) SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Innovaderm and/or Sponsor' standards and interpretation of CDISC. - Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. - Participate in internal initiatives to increase efficiency and/or quality of Statistical Programming activities/deliverables, including but not limited to development/improvement/validation of standard macros, templates, and programming standards and processes. - Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. - May also: - Review and provide input into various DM documents (e.g., electronic Case Report Forms [eCRF], edit checks, etc.), Statistical Analysis Plans (SAPs), and Table, Listing, and Figure (TLF) Shells. - Act as a Lead Statistical Programmer on single studies. - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Qualifications - Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset. - At least 1 year of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 1 year of Statistical Programming. - Significant exposure to clinical trial data, SAP, TLF Shells, and specifications. - Excellent working knowledge of SAS; SAS certification an asset. - Knowledge of XML programming an asset. - Good knowledge of CDISC standards and guidelines; CDISC certification an asset. - Good knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry Good Programming Practices (GPP). - Very organized and detail-oriented, with effective project planning and time management skills. - Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. - Must be able to work independently and as part of a team. - Strong verbal and written communication skills in English; French an asset. Benefits - Permanent full-time position - Flexible schedule - Home-based position - Ongoing learning and development Company Description At Indero, formerly Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Indero, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formerly Innovaderm continues to grow and expand in North America and Europe. Indero, formerly Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formerly Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero, formerly Innovaderm only accepts applicants who can legally work in Romania.

Romania
SecurityScorecard logo

Guidewire Claims Center Developer

SecurityScorecard

SecurityScorecard is the global leader in cybersecurity ratings.

Full TimeRemoteTeam 501-1,000Since 2013H1B Sponsor

Title: Guidewire Claims Center Developer Location Plano,TX-8383 DominionPkwy / United States Job category Business Processes Work model Work from Home 00068710501 Job Description: Technical Lead – Guidewire ClaimCenter (Java / Cloud) United States (Remote) About Cognizant Cognizant is one of the world’s leading professional services companies, transforming clients’ business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Role Overview Cognizant is seeking an experienced Technical Lead / Senior Developer with strong expertise in Guidewire ClaimCenter, Java Spring/Spring Boot, and cloud platforms to support U.S.-based insurance clients. This is a full-time, remote position supporting distributed delivery teams across the United States. Responsibilities - Lead estimation, solution design, and technical planning for Guidewire ClaimCenter and digital implementations. - Create detailed technical design and specification documents for Guidewire ClaimCenter, Spring Boot, APIs, web services, and digital solutions. - Develop efficient, high-quality, and scalable code aligned with product and delivery standards. - Conduct peer code reviews and testing reviews; log and track defects using approved tools. - Support defect analysis and resolution in collaboration with senior specialists and QA teams. - Define GUnit testing strategies and support QA during system and integration testing. - Participate in deployment activities including deliverable reviews, deployment documentation, and mock testing. - Develop reusable components and maintain knowledge transfer (KT) documentation for customers. - Provide estimation inputs, impact analysis, and accurate reporting of time, effort, and status. - Mentor junior team members and conduct Guidewire technical training sessions. - Participate in technical interviews for Guidewire Technical Lead and Architect roles. Qualifications - 8–10 years of overall enterprise application development experience. - 5–6 years of hands-on experience with Guidewire ClaimCenter. - Mandatory active Guidewire ClaimCenter Certification (Associate level or higher). - Strong experience with Java, Spring Framework, and Spring Boot. - Hands-on experience with cloud platforms such as AWS or Azure. - Solid understanding of REST APIs, web services, and integration patterns. - Ability to work effectively in a remote, distributed U.S. delivery model. Preferred Qualifications - Experience with insurance digital portals and Guidewire Edge/API services. - Additional Guidewire, AWS, or Azure certifications. - Experience working in Agile/Scrum delivery environments. Compensation The annual base salary range for this role is $120,000 – $155,000 USD. This position is also eligible for Cognizant’s discretionary annual incentive program and a comprehensive benefits package. Compensation may vary based on geographic location, skills, experience, and internal equity. Work Authorization Applicants must be legally authorized to work in the United States without the need for current or future visa sponsorship. Equal Opportunity Employer Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The Cognizant community: We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive. - Cognizant is a global community with more than 300,000 associates around the world. - We don’t just dream of a better way – we make it happen. - We take care of our people, clients, company, communities and climate by doing what’s right. - We foster an innovative environment where you can build the career path that’s right for you. About us: Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world.

United States
$120K - $155K / year
Full TimeRemoteTeam 1,001-5,000

Role Description This position is fully remote. In order to qualify for this role with UniGroup, you must live in one of the following states: Missouri, Illinois, Arkansas, Georgia, Tennessee, North Carolina, Texas, Florida, or Indiana. Preference will be given to local candidates. The Staff Software Engineer designs, develops, tests, and supports UniGroup’s core business applications running in a mainframe environment. This role plays a critical part in maintaining and enhancing systems that support order processing, billing, and transportation operations across the organization. The Software Engineer collaborates closely with other engineers, analysts, and business partners to support daily operations, ensure system stability, and contribute to efforts that reduce reliance on legacy platforms over time. This is a hands-on role well-suited for someone who enjoys working in established systems while supporting modernization through testing, documentation, and technical partnership. Responsibilities - Design, develop, test, and support software applications within a mainframe environment - Write, maintain, and debug COBOL programs supporting core business systems - Support CI/CS environments and applications using DB2 as the primary database - Utilize JCL and TSO to manage batch processing, job execution, and system operations - Use mainframe utilities such as QMF and SCLM to support development, testing, and source control - Partner with senior engineers to test, validate, and support work related to mainframe modernization efforts - Support production systems, including troubleshooting issues related to order, billing, and transportation systems - Participate in code reviews and testing efforts to ensure accuracy, performance, and system reliability - Maintain technical documentation and contribute to knowledge sharing within the team - Collaborate with cross-functional partners to understand business requirements and translate them into technical solutions - Assist in workload balancing by supporting and testing work completed by other engineers - Perform other duties as assigned Qualifications - Required: Bachelor’s degree in Computer Science, Information Systems, or a related field, or equivalent professional experience - 8+ years of experience in software development or application support within a mainframe environment - Hands-on experience with COBOL development and maintenance - Working knowledge of DB2, JCL, and TSO - Experience supporting production systems in a CI/CS environment - Demonstrated ability to troubleshoot, test, and validate changes in legacy systems - Strong collaboration and communication skills - Preferred: Exposure to mainframe modernization or migration initiatives - Familiarity with mainframe utilities such as QMF and SCLM Benefits - We foster diversity, in part, by imposing a strict policy of non-discrimination. Employment decisions are made without regard to race, color, ethnicity, national origin, sex, sexual orientation, gender identity, age, religion, disability, veteran or military status, genetic information or other status protected by the law. - We value the unique skills and experiences that veterans and separated service members bring to our workforce. While serving our country you have gained skills such as leadership, flexibility, and agility, which will help to make you successful here. - We are dedicated to supporting military families and ensuring that we provide a welcoming environment for our country’s heroes. - UniGroup is committed to the full inclusion of all qualified individuals. As part of this commitment, UniGroup will ensure that persons with disabilities are provided reasonable accommodations. - If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact careers@unigroup.com

United States
Job Closed

Geographic Information Systems Programmer Location: Towson United States 90,000-100,000 per year Salary Full Time Work from home flexibility Job Description: EBA Engineering, Inc. (EBA) is seeking qualified Senior GIS Programmers to support Baltimore County's Office of Information Technology (OIT/BAU) in Towson, Maryland. This position will support enterprise GIS application development, ArcGIS Server administration and maintenance, GIS application upgrades, and Cityworks integration efforts. This is a hybrid role based in Towson, MD, with some on-site work required. Following approximately six months of successful performance and integration with the team, the position may transition to a more remote-based schedule in coordination with the project manager and client requirements. KEY RESPONSIBILITIES As a Senior GIS Programmer, you will: - Develop, maintain, and upgrade GIS applications and web-based GIS solutions - Support ArcGIS Server application development and ongoing maintenance activities - Assist with configuration efforts in CityWorks and associated GIS web services - Repair and enhance Facilities and Utility toolsets developed in Visual C# using Visual Studio and ArcObjects SDK - Analyze, troubleshoot, and resolve application and production issues - Develop reports and database solutions using SSRS, SQL, triggers, and stored procedures - Collaborate with technical teams, stakeholders, and end users to support GIS initiatives and operational needs - Support ArcGIS Web AppBuilder applications and ArcGIS Server environments MINIMUM QUALIFICATIONS - Minimum of five (5) years of experience developing and modifying applications using J2EE, .NET, JavaScript, HTML, C#, and Python - Experience with ESRI ArcGIS technologies including ArcGIS Server, ArcGIS APIs, ArcGIS JavaScript API, ArcGIS Web AppBuilder, Collector, ArcSDE, and ArcGIS Mobile - Experience with ArcGIS ModelBuilder and Python scripting - Strong knowledge of SQL, database triggers, and stored procedures - Experience developing reports using SSRS - Strong understanding of relational database concepts, preferably Oracle and SQL Server - Experience analyzing and resolving production and application issues - Excellent verbal and written communication skills PREFERRED QUALIFICATIONS - Bachelor's degree from an accredited college or university in Business, Computer Science, GIS, Information Systems, or a related field - Recent experience supporting a government agency or public-sector client - Experience supporting enterprise GIS environments and CityWorks integrations SUBMISSION REQUIREMENTS Candidates must provide: - At least two professional references, including phone numbers, where the candidate performed similar services - An updated resume clearly demonstrating the required technical qualifications and experience BENEFITS: We provide a comprehensive benefits package designed to support your career growth and well-being. Our offerings include a competitive salary and robust compensation package, hybrid schedule, flexible work hours, comprehensive health benefits-including medical, dental, vision, and prescription coverage-and participation in a wellness rewards program that can eliminate medical deductibles, a 401(k) plan with company-matching contributions, flexible spending accounts, company-paid short- and long-term disability insurance, company-paid life insurance, company-paid AD&D, paid holidays and vacation time, and reimbursement for tuition, certifications, and licensure to support your ongoing professional development.

Maryland
$90K - $100K / year