Job Description
I
Innovaderm Research
Senior Statistical Programmer (India)
Innovaderm Research • via Innovaderm Research
7 days ago
Full–time
No Degree Mentioned
Apply directly on Innovaderm Research
Apply on Cytel
Job 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 to 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’ 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 to 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.
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Asentech
Senior Tester
Asentech • via Instahyre
Full–time
No Degree Mentioned
Apply on Instahyre
Job description
Highly motivated and experienced Senior Tester to join our Payroll team. As a Senior Tester, you will play a pivotal role in ensuring the quality and accuracy of our payroll system, ensuring seamless and reliable payroll processing for our clients. You will be responsible for designing, executing, and documenting comprehensive test cases, identifying and reporting defects, and working collaboratively with developers to resolve issues. This is an excellent opportunity for a passionate and detail-oriented individual to contribute to the success of a growing and innovative company.
Responsibilities:
• Develop and maintain comprehensive test plans and test cases for payroll system functionality.
• Execute test cases, analyze results, and document defects in a clear and concise manner.
• Collaborate with developers to resolve defects and ensure timely fixes.
• Perform regression testing to ensure that new features and changes do not impact existing functionality.
• Stay updated on industry best practices and emerging trends in payroll testing.
Requirements:
• Minimum 0 to 30 years of experience in software testing, with a strong emphasis on payroll systems.
• In-depth understanding of payroll processes, regulations, and best practices.
• Proficiency in test case design, execution, and documentation.
• Experience with various testing methodologies, including functional, regression, integration, and performance testing.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
Innovaderm Research
Senior Statistical Programmer (India)
Innovaderm Research • via Innovaderm Research
7 days ago
Full–time
No Degree Mentioned
Apply directly on Innovaderm Research
Apply on Cytel
Job 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 to 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’ 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 to 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.
Report this listing
Innovaderm Research
Glassdoor
4.1/5
48 reviews
AmbitionBox
3.2/5
7 reviews
Indeed
2.5/5
2 reviews
innovaderm.com
More jobs at Innovaderm Research
See web results for Innovaderm Research
Asentech
Senior Tester
Asentech • via Instahyre
Full–time
No Degree Mentioned
Apply on Instahyre
Job description
Highly motivated and experienced Senior Tester to join our Payroll team. As a Senior Tester, you will play a pivotal role in ensuring the quality and accuracy of our payroll system, ensuring seamless and reliable payroll processing for our clients. You will be responsible for designing, executing, and documenting comprehensive test cases, identifying and reporting defects, and working collaboratively with developers to resolve issues. This is an excellent opportunity for a passionate and detail-oriented individual to contribute to the success of a growing and innovative company.
Responsibilities:
• Develop and maintain comprehensive test plans and test cases for payroll system functionality.
• Execute test cases, analyze results, and document defects in a clear and concise manner.
• Collaborate with developers to resolve defects and ensure timely fixes.
• Perform regression testing to ensure that new features and changes do not impact existing functionality.
• Stay updated on industry best practices and emerging trends in payroll testing.
Requirements:
• Minimum 0 to 30 years of experience in software testing, with a strong emphasis on payroll systems.
• In-depth understanding of payroll processes, regulations, and best practices.
• Proficiency in test case design, execution, and documentation.
• Experience with various testing methodologies, including functional, regression, integration, and performance testing.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
💡 Quick Summary
Seeking a career-building opportunity? The Senior Tester position is now open for candidates interested in the Work from home Jobs sector. This role in Ajmer offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Work from home Jobs is a plus.