As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Jan 21, 2020
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Jan 21, 2020
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Exciting opportunity to join Abbott's fastest growing medical device division, Diabetes Care (ADC). Home of the FreeStyle Libre.
PRIMARY FUNCTION: Responsible for developing standards for world-wide capacity planning integrated with global supply planning, incorporating information from capacity expansion program, capital expenditures, and long term planning.
Scope of this role includes global capacity planning for finished goods and components across product categories. Includes close interaction with third party manufacturers in understanding true capacity constraints in the short and long term. Responsible to provide capacity input to IBP TPM (third party manufacturing) process and IBP demand control process.
Work cross functional with international commercial operations, finances, R&D, program and global sourcing teams to ensure market successfully new product introductions, improved product availability, and thorough understanding of component and finished goods capacity and constraints.
MAJOR RESPONSIBILITIES: Provide leadership and integration of capacity planning with global supply planning and component planning activities. Incorporate capacity plans into decision making to meet division strategies and goals for product availability and costs by taking into consideration material and capacity constraints. Responsible for running the RCCP process to streamline capacity availability. Provide input and support to the implementation of the integrated business processes and long- range plan. Work with other global supply chain organization to identify and implement supply chain and capacity optimization projects to reduce costs, lead time, and improve product availability. Support the development and implementation of planning systems. Manage the coordination and integration of data from multiple software systems to facility divisional reporting and planning activities. Integrate capacity planning with supply planning activities in connections with product introductions and discontinuation to ensure smooth and effective program execution, minimizing obsolescence while ensuring product availability. Be proactive and direct in communicating opportunities, issues and requirements ensuring that management and senior staff are current on all critical matters, with a focus on resolution alternatives, recommendations and implementation planning, costs and benefits. Maintain and develop positive relationships with commercial affiliates, global forecasting, program, finance, global sourcing and R&D to positively influence decision-making and improve performance.
QUALIFICATIONS:
Bachelor's of Science required, Masters preferred
Ideally, APICS CPIM certified
6-10 years of relevant experience in sales & operation planning, production planning, master scheduling, logistics management, inventory planning, supplier management, project management, customer service, supply planning, or demand planning
Proven leadership skills, results oriented, team player, self-starter who can operation in a dynamic and diverse environment
Extensive experience in management information systems development and implementation
Medical device background preferred
Jan 21, 2020
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Exciting opportunity to join Abbott's fastest growing medical device division, Diabetes Care (ADC). Home of the FreeStyle Libre.
PRIMARY FUNCTION: Responsible for developing standards for world-wide capacity planning integrated with global supply planning, incorporating information from capacity expansion program, capital expenditures, and long term planning.
Scope of this role includes global capacity planning for finished goods and components across product categories. Includes close interaction with third party manufacturers in understanding true capacity constraints in the short and long term. Responsible to provide capacity input to IBP TPM (third party manufacturing) process and IBP demand control process.
Work cross functional with international commercial operations, finances, R&D, program and global sourcing teams to ensure market successfully new product introductions, improved product availability, and thorough understanding of component and finished goods capacity and constraints.
MAJOR RESPONSIBILITIES: Provide leadership and integration of capacity planning with global supply planning and component planning activities. Incorporate capacity plans into decision making to meet division strategies and goals for product availability and costs by taking into consideration material and capacity constraints. Responsible for running the RCCP process to streamline capacity availability. Provide input and support to the implementation of the integrated business processes and long- range plan. Work with other global supply chain organization to identify and implement supply chain and capacity optimization projects to reduce costs, lead time, and improve product availability. Support the development and implementation of planning systems. Manage the coordination and integration of data from multiple software systems to facility divisional reporting and planning activities. Integrate capacity planning with supply planning activities in connections with product introductions and discontinuation to ensure smooth and effective program execution, minimizing obsolescence while ensuring product availability. Be proactive and direct in communicating opportunities, issues and requirements ensuring that management and senior staff are current on all critical matters, with a focus on resolution alternatives, recommendations and implementation planning, costs and benefits. Maintain and develop positive relationships with commercial affiliates, global forecasting, program, finance, global sourcing and R&D to positively influence decision-making and improve performance.
QUALIFICATIONS:
Bachelor's of Science required, Masters preferred
Ideally, APICS CPIM certified
6-10 years of relevant experience in sales & operation planning, production planning, master scheduling, logistics management, inventory planning, supplier management, project management, customer service, supply planning, or demand planning
Proven leadership skills, results oriented, team player, self-starter who can operation in a dynamic and diverse environment
Extensive experience in management information systems development and implementation
Medical device background preferred
Providing critical support for Penumbra’s clinical trials, you will prepare SAS programs to enable the preparation and statistical analysis of clinical data. You will coordinate the statistical programming activities for multiple clinical projects and partner with other programmers, statisticians, and clinical data managers in the collection, analysis, and reporting of clinical data for trials. This is a contract position planned to last a duration of 6-12 months.
The job
Independently lead and perform all statistical programming activities for your projects.
Creating the clinical trial data sets and programs for regulatory submissions and ensuring their accuracy.
Help develop the SAPs for our clinical studies and interpret statistical analysis plans to develop analysis and data set specifications.
Determine scope of peer reviews and ensure that the accuracy of the SAS programs by reviewing the output, code, and log files.
Maintain expertise in the use of SAS Macros, formulate proposals and create new SAS macros while maintaining existing Macros.
Identifying opportunities for productivity improvements and figuring out implementation plans.
Serve as statistical programming SME, providing specific expertise on timeline development, identification of statistical programming deliverables and resource requirements helping create, review, and maintain project timelines and monitor progress of statistical programming activities.
Interact with data management, biostatistics, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors.
Mentor other statistical programmers and monitor their performance.
Provide input into SOP reviews and write effective SOP's on statistical programming.
What you bring
The desire to take on complex challenges and work with a great team.
Bachelor’s or Masters degree in Statistics, Computer Science, or a similar quantitative field with a minimum of 7-12 years or relevant experience of combined educational and job experience.
Competence in SAS programming and Macro development.
Experience with clinical trials, including familiarity with expectations of regulatory agencies, FDA preferred.
Ability to interpret statistical analysis plans to develop analysis data set specifications.
SAS Certified Base and/or Advance Programmer experience preferred.
Excellent oral, written, and interpersonal communication skills.
Attention to detail and the ability to handle multiple tasks.
What we offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Jan 21, 2020
Providing critical support for Penumbra’s clinical trials, you will prepare SAS programs to enable the preparation and statistical analysis of clinical data. You will coordinate the statistical programming activities for multiple clinical projects and partner with other programmers, statisticians, and clinical data managers in the collection, analysis, and reporting of clinical data for trials. This is a contract position planned to last a duration of 6-12 months.
The job
Independently lead and perform all statistical programming activities for your projects.
Creating the clinical trial data sets and programs for regulatory submissions and ensuring their accuracy.
Help develop the SAPs for our clinical studies and interpret statistical analysis plans to develop analysis and data set specifications.
Determine scope of peer reviews and ensure that the accuracy of the SAS programs by reviewing the output, code, and log files.
Maintain expertise in the use of SAS Macros, formulate proposals and create new SAS macros while maintaining existing Macros.
Identifying opportunities for productivity improvements and figuring out implementation plans.
Serve as statistical programming SME, providing specific expertise on timeline development, identification of statistical programming deliverables and resource requirements helping create, review, and maintain project timelines and monitor progress of statistical programming activities.
Interact with data management, biostatistics, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors.
Mentor other statistical programmers and monitor their performance.
Provide input into SOP reviews and write effective SOP's on statistical programming.
What you bring
The desire to take on complex challenges and work with a great team.
Bachelor’s or Masters degree in Statistics, Computer Science, or a similar quantitative field with a minimum of 7-12 years or relevant experience of combined educational and job experience.
Competence in SAS programming and Macro development.
Experience with clinical trials, including familiarity with expectations of regulatory agencies, FDA preferred.
Ability to interpret statistical analysis plans to develop analysis data set specifications.
SAS Certified Base and/or Advance Programmer experience preferred.
Excellent oral, written, and interpersonal communication skills.
Attention to detail and the ability to handle multiple tasks.
What we offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
