Associate Director, TA Analysis Standards Leader - Bristol Myers Squibb
Princeton, NJ
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Associate Director, TA (Therapeutic Area) Analysis Standards Leader is accountable for developing and promoting the strategy and infrastructure for creation, maintenance, and implementation of analysis standards across the TA, aligning cross-functionally and driving end to end standards.
Associate Director, TA Analysis Standards Leader, independently leads improvement initiatives under sponsoring of Therapeutic Area Head or Statistical Programming leadership team. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate development and implementation of Analysis Standards, including Data Visualization specifications for the Therapeutic Area. Managers also lead the change management process (e.g. communication, training, stakeholder engagement).
This position includes project and product management responsibilities. In this role, Associate Director, TA Analysis Standards Leader, is responsible for setting objectives for standards and provide meaningful coaching and feedback to team members working on standards. They also support the evaluation and recruitment of potential employees and may have direct reports.
Strategy: Develops Analysis Standards strategy for assigned therapeutic area in collaboration with key stakeholders utilizing risk-based approaches and differentiating early clinical development and late phase strategies. Leads implementation of analysis standards practices across the value chain, and utilizes standards adherence metrics to showcase value.
Execution: Leads development of a robust and scalable cross-functional analysis standards solutions and responsible for promotion of analysis standards value throughout Global Drug Development. Ensures consistent approach to implementation and governance of clinical analysis standards across Therapeutic areas in partnership with the Head of Analysis Standards Governance. Accountable for overall adherence to analysis standards industry regulations and guidance while maintaining emphasis on exceptional analysis quality. Act as expert consultant for escalated issues for TA level analysis standards.
External Industry Involvement: Possesses influential, external-facing focus, and demonstrates application and harmonization of industry best practices. Represents BMS on external teams utilizing analysis standards knowledge and expertise, leading when appropriate. Coordinates communication and education of industry best practices within and across TA / GBDS. Process Improvement and Innovation: Identifies and drives analysis standards related initiatives to enhance efficiencies within the end to end analysis deliverables. Collaborates to identify innovative technical advances, elevating the value of analysis standards. Evaluates analysis standards and governance processes and metrics for continuous improvement opportunities.
Leadership and Management: Provides leadership in best practices for analysis standards development. Provides leadership and management of analysis standards outputs and proposes / executes operational strategy/improvements.
Analysis TA Standards: Key authority on clinical analysis standards both within BMS and externally, and collaborates with other leaders to appropriately employ analysis standards policies and guidance. Has a strong external presence in the Industry, both Influencing external trends in analysis standards and applying external knowledge within Biometrics and across other groups within Global Drug Development.
Minimum Requirements:
+ Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required
+ At least 10 years programming experience in industry including support of significant regulatory filings and extensive knowledge of analysis standards
+ For US positions: US military experience will be considered towards industry experience
+ 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 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
+ Demonstrated ability establish effective business relationships with internal and external stakeholders, including implementing process change internally and at a vendor
+ Demonstrated ability to influence without authority
+ Excellent written and oral communication skills
Preferred Requirements:
+ Member of industry organizations or presented at Congresses/Conferences
+ Immunology Therapeutic Experience
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1583053
Updated: 2024-11-11 04:13:25.527 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Associate Director, TA (Therapeutic Area) Analysis Standards Leader is accountable for developing and promoting the strategy and infrastructure for creation, maintenance, and implementation of analysis standards across the TA, aligning cross-functionally and driving end to end standards.
Associate Director, TA Analysis Standards Leader, independently leads improvement initiatives under sponsoring of Therapeutic Area Head or Statistical Programming leadership team. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate development and implementation of Analysis Standards, including Data Visualization specifications for the Therapeutic Area. Managers also lead the change management process (e.g. communication, training, stakeholder engagement).
This position includes project and product management responsibilities. In this role, Associate Director, TA Analysis Standards Leader, is responsible for setting objectives for standards and provide meaningful coaching and feedback to team members working on standards. They also support the evaluation and recruitment of potential employees and may have direct reports.
Strategy: Develops Analysis Standards strategy for assigned therapeutic area in collaboration with key stakeholders utilizing risk-based approaches and differentiating early clinical development and late phase strategies. Leads implementation of analysis standards practices across the value chain, and utilizes standards adherence metrics to showcase value.
Execution: Leads development of a robust and scalable cross-functional analysis standards solutions and responsible for promotion of analysis standards value throughout Global Drug Development. Ensures consistent approach to implementation and governance of clinical analysis standards across Therapeutic areas in partnership with the Head of Analysis Standards Governance. Accountable for overall adherence to analysis standards industry regulations and guidance while maintaining emphasis on exceptional analysis quality. Act as expert consultant for escalated issues for TA level analysis standards.
External Industry Involvement: Possesses influential, external-facing focus, and demonstrates application and harmonization of industry best practices. Represents BMS on external teams utilizing analysis standards knowledge and expertise, leading when appropriate. Coordinates communication and education of industry best practices within and across TA / GBDS. Process Improvement and Innovation: Identifies and drives analysis standards related initiatives to enhance efficiencies within the end to end analysis deliverables. Collaborates to identify innovative technical advances, elevating the value of analysis standards. Evaluates analysis standards and governance processes and metrics for continuous improvement opportunities.
Leadership and Management: Provides leadership in best practices for analysis standards development. Provides leadership and management of analysis standards outputs and proposes / executes operational strategy/improvements.
Analysis TA Standards: Key authority on clinical analysis standards both within BMS and externally, and collaborates with other leaders to appropriately employ analysis standards policies and guidance. Has a strong external presence in the Industry, both Influencing external trends in analysis standards and applying external knowledge within Biometrics and across other groups within Global Drug Development.
Minimum Requirements:
+ Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required
+ At least 10 years programming experience in industry including support of significant regulatory filings and extensive knowledge of analysis standards
+ For US positions: US military experience will be considered towards industry experience
+ 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 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
+ Demonstrated ability establish effective business relationships with internal and external stakeholders, including implementing process change internally and at a vendor
+ Demonstrated ability to influence without authority
+ Excellent written and oral communication skills
Preferred Requirements:
+ Member of industry organizations or presented at Congresses/Conferences
+ Immunology Therapeutic Experience
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1583053
Updated: 2024-11-11 04:13:25.527 UTC
Location: Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
