Manager, Statistical Programming
Bristol-Myers Squibb
Manager, Statistical Programming
Job Description
Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry recommended. Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. Have worked on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml) Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e.g. R) Experience with the Linux operating system
About the Role/Company
- Part of Global Biometric and Data Sciences (GBDS) department
Key Responsibilities
- Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures
- Perform programming validation to ensure quality of analysis datasets and programming outputs
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
- Support the electronic submission preparation and review
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
- Assess impact on programming activities
- Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers
- Provide leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices
- Identify opportunities for increased efficiency and consistency within GBDS and interactions with strategic vendors
- Independently lead and/or perform programming assignments with minimal supervision
- Support improvement initiatives
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences
- At least 5 years of programming experience in the industry
- Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database
- Experience working on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml)
- Minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development
- Supporting regulatory filings (e.g., NDA, BLA, MAA)
Preferred Qualifications
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements
- Experience in other software packages (e.g., R)
- Experience with the Linux operating system
Skills Required
- Demonstrated skills in using software tools and applications, e.g., MS Office, XML, Pinnacle 21
- Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
- Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
- Good understanding of regulatory, industry, and technology standards and requirements
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
- Demonstrated ability to work in a team environment with clinical team members
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated skills in using software tools and applications, e.g., MS Office, XML, Pinnacle 21intermediate
- Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTMintermediate
- Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submissionintermediate
- Good understanding of regulatory, industry, and technology standards and requirementsintermediate
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designsintermediate
- Demonstrated ability to work in a team environment with clinical team membersintermediate
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences (experience)
- At least 5 years of programming experience in the industry (experience)
- Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs (experience)
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database (experience)
- Experience working on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml) (experience)
- Minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development (experience)
- Supporting regulatory filings (e.g., NDA, BLA, MAA) (experience)
Preferred Qualifications
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements (experience)
- Experience in other software packages (e.g., R) (experience)
- Experience with the Linux operating system (experience)
Responsibilities
- Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures
- Perform programming validation to ensure quality of analysis datasets and programming outputs
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
- Support the electronic submission preparation and review
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
- Assess impact on programming activities
- Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers
- Provide leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices
- Identify opportunities for increased efficiency and consistency within GBDS and interactions with strategic vendors
- Independently lead and/or perform programming assignments with minimal supervision
- Support improvement initiatives
Tags & Categories
Manager, Statistical Programming
Bristol-Myers Squibb
Manager, Statistical Programming
Job Description
Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry recommended. Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. Have worked on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml) Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e.g. R) Experience with the Linux operating system
About the Role/Company
- Part of Global Biometric and Data Sciences (GBDS) department
Key Responsibilities
- Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures
- Perform programming validation to ensure quality of analysis datasets and programming outputs
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
- Support the electronic submission preparation and review
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
- Assess impact on programming activities
- Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers
- Provide leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices
- Identify opportunities for increased efficiency and consistency within GBDS and interactions with strategic vendors
- Independently lead and/or perform programming assignments with minimal supervision
- Support improvement initiatives
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences
- At least 5 years of programming experience in the industry
- Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database
- Experience working on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml)
- Minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development
- Supporting regulatory filings (e.g., NDA, BLA, MAA)
Preferred Qualifications
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements
- Experience in other software packages (e.g., R)
- Experience with the Linux operating system
Skills Required
- Demonstrated skills in using software tools and applications, e.g., MS Office, XML, Pinnacle 21
- Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
- Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
- Good understanding of regulatory, industry, and technology standards and requirements
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
- Demonstrated ability to work in a team environment with clinical team members
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated skills in using software tools and applications, e.g., MS Office, XML, Pinnacle 21intermediate
- Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTMintermediate
- Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submissionintermediate
- Good understanding of regulatory, industry, and technology standards and requirementsintermediate
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designsintermediate
- Demonstrated ability to work in a team environment with clinical team membersintermediate
Required Qualifications
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences (experience)
- At least 5 years of programming experience in the industry (experience)
- Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs (experience)
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational database (experience)
- Experience working on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml) (experience)
- Minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development (experience)
- Supporting regulatory filings (e.g., NDA, BLA, MAA) (experience)
Preferred Qualifications
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements (experience)
- Experience in other software packages (e.g., R) (experience)
- Experience with the Linux operating system (experience)
Responsibilities
- Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures
- Perform programming validation to ensure quality of analysis datasets and programming outputs
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
- Support the electronic submission preparation and review
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
- Assess impact on programming activities
- Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers
- Provide leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices
- Identify opportunities for increased efficiency and consistency within GBDS and interactions with strategic vendors
- Independently lead and/or perform programming assignments with minimal supervision
- Support improvement initiatives
Tags & Categories