Associate Director, Biostatistics
Company Name:
Bristol-Myers Squibb
The Associate Director, Biostatistics is a core member of the development team. Along with the clinical and regulatory leads, this role is responsible to provide scientific and strategic leadership and has a shared responsibility for developing the clinical/regulatory strategy. Provides strategic input into the design/planning of clinical trials, data analysis approaches, interpretation of findings and crafting of key messages.
Primary
Responsibilities:
Core member of an FDT/EDT/LCMT and key subteams (eg, CDT, KIM). Contributes to all aspects of the development strategy. Partners with the team to prepare a development strategy that will enable the effective and safe utilization of the product.
Assumes a leadership role within the Global Biometric Sciences (GBS) organization by contributing and having influence in the development of GBS capabilities, talent management and sharing of best practices across GBS. Serves as a model of scientific and strategic engagement for their team.
Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development team.
Oversees the selection of trial designs, endpoints, statistical analysis strategy, development of DMC proposals, and contributes to the interpretation of trial results and development of the key messages and their communication.
Together with the GBS Planning and Execution Lead, identifies project resource needs, and, in coordination with the development team, aligns team's approved objectives and timelines with the GBS project level book of work and the allocation of GBS resources to ensure effective delivery.
Has accountability for the GBS team (internal and/or external) to effectively deliver on both scientific accountabilities and operational tasks (e.g. tables, figures, listings), while maintaining compliance with global standards, SOPs and established work processes.
Coordinates the ad hoc analysis process and has decision making authority on acceptance of new analyses.
Effectively communicates with internal scientific governance bodies (e.g. CSC, BDOC), clinical and regulatory partners, external opinion leaders and manages relationships and interactions with development alliance partners.
Builds the external reputation of BMS R&D via external interactions (academic relationships, conference presentations, governmental research organization reviewer, etc).
Presents or responds to questions at Global Regulatory Meetings
Qualifications:
PhD degree in statistics or biostatistics or Master's degree with relevant experience preferred. Significant academic training in statistics, biostatistics or related field.
> 7 years of Pharmaceutical/R&D or other related experience in planning and managing statistical aspects of clinical development projects and clinical trials reporting to support regulatory filings and market access.
Statistical expertise, medical/clinical trials knowledge, and project management skills.
Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement, including the resolution of conflicts or their appropriate escalation.
Demonstrated experience in designing and executing research activities in close collaboration with medical, clinical, regulatory and commercial partners.
Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals.
Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence.
Ability to be flexible and adapt quickly to the changing needs of the organization.
Ability to organize multiple work assignments and establish priorities.
Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.
Excellent verbal and written communications skills.Estimated Salary: $20 to $28 per hour based on qualifications.
Bristol-Myers Squibb
The Associate Director, Biostatistics is a core member of the development team. Along with the clinical and regulatory leads, this role is responsible to provide scientific and strategic leadership and has a shared responsibility for developing the clinical/regulatory strategy. Provides strategic input into the design/planning of clinical trials, data analysis approaches, interpretation of findings and crafting of key messages.
Primary
Responsibilities:
Core member of an FDT/EDT/LCMT and key subteams (eg, CDT, KIM). Contributes to all aspects of the development strategy. Partners with the team to prepare a development strategy that will enable the effective and safe utilization of the product.
Assumes a leadership role within the Global Biometric Sciences (GBS) organization by contributing and having influence in the development of GBS capabilities, talent management and sharing of best practices across GBS. Serves as a model of scientific and strategic engagement for their team.
Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development team.
Oversees the selection of trial designs, endpoints, statistical analysis strategy, development of DMC proposals, and contributes to the interpretation of trial results and development of the key messages and their communication.
Together with the GBS Planning and Execution Lead, identifies project resource needs, and, in coordination with the development team, aligns team's approved objectives and timelines with the GBS project level book of work and the allocation of GBS resources to ensure effective delivery.
Has accountability for the GBS team (internal and/or external) to effectively deliver on both scientific accountabilities and operational tasks (e.g. tables, figures, listings), while maintaining compliance with global standards, SOPs and established work processes.
Coordinates the ad hoc analysis process and has decision making authority on acceptance of new analyses.
Effectively communicates with internal scientific governance bodies (e.g. CSC, BDOC), clinical and regulatory partners, external opinion leaders and manages relationships and interactions with development alliance partners.
Builds the external reputation of BMS R&D via external interactions (academic relationships, conference presentations, governmental research organization reviewer, etc).
Presents or responds to questions at Global Regulatory Meetings
Qualifications:
PhD degree in statistics or biostatistics or Master's degree with relevant experience preferred. Significant academic training in statistics, biostatistics or related field.
> 7 years of Pharmaceutical/R&D or other related experience in planning and managing statistical aspects of clinical development projects and clinical trials reporting to support regulatory filings and market access.
Statistical expertise, medical/clinical trials knowledge, and project management skills.
Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement, including the resolution of conflicts or their appropriate escalation.
Demonstrated experience in designing and executing research activities in close collaboration with medical, clinical, regulatory and commercial partners.
Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals.
Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence.
Ability to be flexible and adapt quickly to the changing needs of the organization.
Ability to organize multiple work assignments and establish priorities.
Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.
Excellent verbal and written communications skills.Estimated Salary: $20 to $28 per hour based on qualifications.
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