Associate Director, Biostatistics
Bristol-Myers Squibb
Associate Director, Biostatistics
Job Description
Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols. Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents Presents summary data and analyses results, in a clear, concise, complete, and transparent manner Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design. Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable Contributes to external and internal statistical community of practice Develops & advises team members Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Provides leadership to empower and develop the team. Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff. PhD (6+ years' experience) or MS (8+ years' experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation. Great interpersonal, communication, writing and organizational skills Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework Good understanding of regulatory landscape and experience with participating in regulatory interactions Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills People manager experience is preferred (for people manager position only)
About the Role/Company
- The company emphasizes a culture of inclusiveness and respect for diversity
- The company encourages compliance with processes and allows for respectful and constructive questioning and challenging
- The company's GBDS Mission and Vision aim to generate pride, excitement, and commitment within GBDS
Key Responsibilities
- Collaborate in the design of innovative and efficient clinical trials, including selection of study population/endpoints
- Contribute to project development strategy
- Defend protocols and analysis plans at internal governance reviews
- Provide independent reviews of complex protocols
- Independently author and/or review protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
- Present summary data and analyses results clearly, concisely, completely, and transparently
- Provide statistical support and leadership to address health authority requests, publications, presentations, and other public releases of information
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
- Apply extensive knowledge of statistical/clinical trials methodology to clinical development
- Invest in developing knowledge outside of traditional statistical expertise in clinical, regulatory, and commercial environments
- Effectively engage as a matrix team member on project teams, acting as a scientific and strategic partner in the drug development process
- Comply with BMS processes and SOPs, adhere to global and project standards within an indication or therapeutic area, and be responsible for the quality of deliverables
- Contribute to external and internal statistical community of practice
- Develop and advise team members
- Effectively communicate the GBDS Mission and Vision to generate pride, excitement, and commitment within GBDS
- Enable a culture of inclusiveness, respect for diversity, compliance with process, and allow for respectful and constructive questioning and challenging
- Provide leadership to empower and develop the team
- Provide guidance to employees' development plans and carry out performance reviews and feedback
- Develop performance metrics for staff
Required Qualifications
- PhD with 6+ years' experience or MS with 8+ years' experience in statistics, biostatistics, or related scientific field
- Experience in clinical trials, drug development, pharmaceutical industry, or healthcare
Preferred Qualifications
- People manager experience
Skills Required
- Proficiency in scientific computing/programming (SAS, R, or Python)
- Ability to implement advanced statistical analysis, data manipulation, graphing, and simulation
- Great interpersonal, communication, writing, and organizational skills
- Expertise in statistical/clinical trials methodology as it relates to clinical development
- Ability to apply statistical/clinical trials methodology to relevant clinical development framework
- Good understanding of regulatory landscape and experience with participating in regulatory interactions
- Demonstrated collaboration, organizational/leadership abilities, and interpersonal skills
- Ability to plan, organize, and prioritize multiple work assignments
- Strong project management skills
Locations
- Warsaw, United States
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficiency in scientific computing/programming (SAS, R, or Python)intermediate
- Ability to implement advanced statistical analysis, data manipulation, graphing, and simulationintermediate
- Great interpersonal, communication, writing, and organizational skillsintermediate
- Expertise in statistical/clinical trials methodology as it relates to clinical developmentintermediate
- Ability to apply statistical/clinical trials methodology to relevant clinical development frameworkintermediate
- Good understanding of regulatory landscape and experience with participating in regulatory interactionsintermediate
- Demonstrated collaboration, organizational/leadership abilities, and interpersonal skillsintermediate
- Ability to plan, organize, and prioritize multiple work assignmentsintermediate
- Strong project management skillsintermediate
Required Qualifications
- PhD with 6+ years' experience or MS with 8+ years' experience in statistics, biostatistics, or related scientific field (experience)
- Experience in clinical trials, drug development, pharmaceutical industry, or healthcare (experience)
Preferred Qualifications
- People manager experience (experience)
Responsibilities
- Collaborate in the design of innovative and efficient clinical trials, including selection of study population/endpoints
- Contribute to project development strategy
- Defend protocols and analysis plans at internal governance reviews
- Provide independent reviews of complex protocols
- Independently author and/or review protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
- Present summary data and analyses results clearly, concisely, completely, and transparently
- Provide statistical support and leadership to address health authority requests, publications, presentations, and other public releases of information
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
- Apply extensive knowledge of statistical/clinical trials methodology to clinical development
- Invest in developing knowledge outside of traditional statistical expertise in clinical, regulatory, and commercial environments
- Effectively engage as a matrix team member on project teams, acting as a scientific and strategic partner in the drug development process
- Comply with BMS processes and SOPs, adhere to global and project standards within an indication or therapeutic area, and be responsible for the quality of deliverables
- Contribute to external and internal statistical community of practice
- Develop and advise team members
- Effectively communicate the GBDS Mission and Vision to generate pride, excitement, and commitment within GBDS
- Enable a culture of inclusiveness, respect for diversity, compliance with process, and allow for respectful and constructive questioning and challenging
- Provide leadership to empower and develop the team
- Provide guidance to employees' development plans and carry out performance reviews and feedback
- Develop performance metrics for staff
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Associate Director, Biostatistics
Bristol-Myers Squibb
Associate Director, Biostatistics
Job Description
Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols. Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents Presents summary data and analyses results, in a clear, concise, complete, and transparent manner Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design. Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable Contributes to external and internal statistical community of practice Develops & advises team members Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Provides leadership to empower and develop the team. Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff. PhD (6+ years' experience) or MS (8+ years' experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation. Great interpersonal, communication, writing and organizational skills Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework Good understanding of regulatory landscape and experience with participating in regulatory interactions Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills People manager experience is preferred (for people manager position only)
About the Role/Company
- The company emphasizes a culture of inclusiveness and respect for diversity
- The company encourages compliance with processes and allows for respectful and constructive questioning and challenging
- The company's GBDS Mission and Vision aim to generate pride, excitement, and commitment within GBDS
Key Responsibilities
- Collaborate in the design of innovative and efficient clinical trials, including selection of study population/endpoints
- Contribute to project development strategy
- Defend protocols and analysis plans at internal governance reviews
- Provide independent reviews of complex protocols
- Independently author and/or review protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
- Present summary data and analyses results clearly, concisely, completely, and transparently
- Provide statistical support and leadership to address health authority requests, publications, presentations, and other public releases of information
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
- Apply extensive knowledge of statistical/clinical trials methodology to clinical development
- Invest in developing knowledge outside of traditional statistical expertise in clinical, regulatory, and commercial environments
- Effectively engage as a matrix team member on project teams, acting as a scientific and strategic partner in the drug development process
- Comply with BMS processes and SOPs, adhere to global and project standards within an indication or therapeutic area, and be responsible for the quality of deliverables
- Contribute to external and internal statistical community of practice
- Develop and advise team members
- Effectively communicate the GBDS Mission and Vision to generate pride, excitement, and commitment within GBDS
- Enable a culture of inclusiveness, respect for diversity, compliance with process, and allow for respectful and constructive questioning and challenging
- Provide leadership to empower and develop the team
- Provide guidance to employees' development plans and carry out performance reviews and feedback
- Develop performance metrics for staff
Required Qualifications
- PhD with 6+ years' experience or MS with 8+ years' experience in statistics, biostatistics, or related scientific field
- Experience in clinical trials, drug development, pharmaceutical industry, or healthcare
Preferred Qualifications
- People manager experience
Skills Required
- Proficiency in scientific computing/programming (SAS, R, or Python)
- Ability to implement advanced statistical analysis, data manipulation, graphing, and simulation
- Great interpersonal, communication, writing, and organizational skills
- Expertise in statistical/clinical trials methodology as it relates to clinical development
- Ability to apply statistical/clinical trials methodology to relevant clinical development framework
- Good understanding of regulatory landscape and experience with participating in regulatory interactions
- Demonstrated collaboration, organizational/leadership abilities, and interpersonal skills
- Ability to plan, organize, and prioritize multiple work assignments
- Strong project management skills
Locations
- Warsaw, United States
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficiency in scientific computing/programming (SAS, R, or Python)intermediate
- Ability to implement advanced statistical analysis, data manipulation, graphing, and simulationintermediate
- Great interpersonal, communication, writing, and organizational skillsintermediate
- Expertise in statistical/clinical trials methodology as it relates to clinical developmentintermediate
- Ability to apply statistical/clinical trials methodology to relevant clinical development frameworkintermediate
- Good understanding of regulatory landscape and experience with participating in regulatory interactionsintermediate
- Demonstrated collaboration, organizational/leadership abilities, and interpersonal skillsintermediate
- Ability to plan, organize, and prioritize multiple work assignmentsintermediate
- Strong project management skillsintermediate
Required Qualifications
- PhD with 6+ years' experience or MS with 8+ years' experience in statistics, biostatistics, or related scientific field (experience)
- Experience in clinical trials, drug development, pharmaceutical industry, or healthcare (experience)
Preferred Qualifications
- People manager experience (experience)
Responsibilities
- Collaborate in the design of innovative and efficient clinical trials, including selection of study population/endpoints
- Contribute to project development strategy
- Defend protocols and analysis plans at internal governance reviews
- Provide independent reviews of complex protocols
- Independently author and/or review protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
- Present summary data and analyses results clearly, concisely, completely, and transparently
- Provide statistical support and leadership to address health authority requests, publications, presentations, and other public releases of information
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
- Apply extensive knowledge of statistical/clinical trials methodology to clinical development
- Invest in developing knowledge outside of traditional statistical expertise in clinical, regulatory, and commercial environments
- Effectively engage as a matrix team member on project teams, acting as a scientific and strategic partner in the drug development process
- Comply with BMS processes and SOPs, adhere to global and project standards within an indication or therapeutic area, and be responsible for the quality of deliverables
- Contribute to external and internal statistical community of practice
- Develop and advise team members
- Effectively communicate the GBDS Mission and Vision to generate pride, excitement, and commitment within GBDS
- Enable a culture of inclusiveness, respect for diversity, compliance with process, and allow for respectful and constructive questioning and challenging
- Provide leadership to empower and develop the team
- Provide guidance to employees' development plans and carry out performance reviews and feedback
- Develop performance metrics for staff
Tags & Categories
Answer 10 quick questions to check your fit for Associate Director, Biostatistics @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs