Senior Programmer - Starszy Programista
Bristol-Myers Squibb
Senior Programmer - Starszy Programista
Job Description
They also support the evaluation and recruitment of potential employees. Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Supporting People with Disabilities Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 7 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS, R or other programming languages to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Management experience supervising technical professionals
Key Responsibilities
- Provide comprehensive programming leadership and support to clinical project teams and vendors
- Deploy programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities according to predefined specifications and standards
- Lead and support the preparation and review of electronic submissions
- Develop unambiguous and robust programming specifications (e.g., ADaM specifications)
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives
- Ensure clarity and completeness of programming assumptions and requirements
- Assess document robustness and impact on programming activities
- Support people with disabilities
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences
- At least 7 years of programming experience in the industry
- Experience supporting significant regulatory filings
Skills Required
- Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology
- Broad expertise in statistical programming and developing computing strategies
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
- Proficiency in using SAS, R, or other programming languages to produce analysis datasets and TFLs
- Proficiency in using other software tools and applications (e.g., MS Office, XML, Pinnacle 21)
- Ability to process upstream data (e.g., multiple data forms, workflows, eDC, SDTM)
- Ability to provide deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components)
- Ability to work in a team environment with clinical team members
- Management experience supervising technical professionals
Locations
- Warsaw, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminologyintermediate
- Broad expertise in statistical programming and developing computing strategiesintermediate
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databasesintermediate
- Proficiency in using SAS, R, or other programming languages to produce analysis datasets and TFLsintermediate
- Proficiency in using other software tools and applications (e.g., MS Office, XML, Pinnacle 21)intermediate
- Ability to process upstream data (e.g., multiple data forms, workflows, eDC, SDTM)intermediate
- Ability to provide deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components)intermediate
- Ability to work in a team environment with clinical team membersintermediate
- Management experience supervising technical professionalsintermediate
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences (experience)
- At least 7 years of programming experience in the industry (experience)
- Experience supporting significant regulatory filings (experience)
Responsibilities
- Provide comprehensive programming leadership and support to clinical project teams and vendors
- Deploy programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities according to predefined specifications and standards
- Lead and support the preparation and review of electronic submissions
- Develop unambiguous and robust programming specifications (e.g., ADaM specifications)
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives
- Ensure clarity and completeness of programming assumptions and requirements
- Assess document robustness and impact on programming activities
- Support people with disabilities
Tags & Categories
Senior Programmer - Starszy Programista
Bristol-Myers Squibb
Senior Programmer - Starszy Programista
Job Description
They also support the evaluation and recruitment of potential employees. Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Supporting People with Disabilities Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 7 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS, R or other programming languages to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Management experience supervising technical professionals
Key Responsibilities
- Provide comprehensive programming leadership and support to clinical project teams and vendors
- Deploy programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities according to predefined specifications and standards
- Lead and support the preparation and review of electronic submissions
- Develop unambiguous and robust programming specifications (e.g., ADaM specifications)
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives
- Ensure clarity and completeness of programming assumptions and requirements
- Assess document robustness and impact on programming activities
- Support people with disabilities
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences
- At least 7 years of programming experience in the industry
- Experience supporting significant regulatory filings
Skills Required
- Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology
- Broad expertise in statistical programming and developing computing strategies
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
- Proficiency in using SAS, R, or other programming languages to produce analysis datasets and TFLs
- Proficiency in using other software tools and applications (e.g., MS Office, XML, Pinnacle 21)
- Ability to process upstream data (e.g., multiple data forms, workflows, eDC, SDTM)
- Ability to provide deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components)
- Ability to work in a team environment with clinical team members
- Management experience supervising technical professionals
Locations
- Warsaw, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminologyintermediate
- Broad expertise in statistical programming and developing computing strategiesintermediate
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databasesintermediate
- Proficiency in using SAS, R, or other programming languages to produce analysis datasets and TFLsintermediate
- Proficiency in using other software tools and applications (e.g., MS Office, XML, Pinnacle 21)intermediate
- Ability to process upstream data (e.g., multiple data forms, workflows, eDC, SDTM)intermediate
- Ability to provide deliverables to meet downstream requirements (e.g., ADaM, TFLs, e-submission components)intermediate
- Ability to work in a team environment with clinical team membersintermediate
- Management experience supervising technical professionalsintermediate
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences (experience)
- At least 7 years of programming experience in the industry (experience)
- Experience supporting significant regulatory filings (experience)
Responsibilities
- Provide comprehensive programming leadership and support to clinical project teams and vendors
- Deploy programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities according to predefined specifications and standards
- Lead and support the preparation and review of electronic submissions
- Develop unambiguous and robust programming specifications (e.g., ADaM specifications)
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives
- Ensure clarity and completeness of programming assumptions and requirements
- Assess document robustness and impact on programming activities
- Support people with disabilities
Tags & Categories