Job Description

POSITION SUMMARY:

The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies space. This role ensures the highest quality of statistical and programming support of our hematopoietic stem cell and cellular therapy clinical trials that further the mission, vision and strategic plan of NMDP. The Manager, Biostatistics role will ensure the statistical aspects of clinical activities meet required standards and are robust and valid. This role directly oversees biostatisticians and statistical programmers including hiring, training, leading, overseeing, reviewing work and coaching for growth and development.

ACCOUNTABILITIES:

Trials oversight:

• Complete statistical design, planning and analysis duties of individual studies, as needed.
• Coordinate and oversee statistical deliverables and programming activities of CRO services clinical trials.
• Collaborate with study statisticians to provide expertise in design of clinical trials.
• Review and approve protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, datafile specifications, clinical study reports, protocol deviations, clinical publications, and other study documents or communications.
• Provide guidance on implementation of statistical analysis plans to the study biostatisticians.
• Develop and maintain statistical and programming policies, guidelines, and procedures (SOPs, training manuals, etc.).
• Develop and maintain a program to train biostatistician and statistical programmer team members, based on current needs of CRO Services portfolio and strategic direction.
• Lead standardization efforts, process improvements, and best practices for the team and contribute to cross-functional process improvement efforts.

Strategic planning:

• Define team goals and strategy on an ongoing basis, in collaboration with the Senior Manager, Biostatistics.
• Provide innovation ideas to Senior Manager, Biostatistics on improving current processes and deliverables including methodology, best practices, and process improvements to maximize biostatistics value and increase efficiency in current resources.

Functional leadership:

• Stay up to date on the latest developments in the statistics and/or programming fields and contribute to scientific advances in the field. Educate the team on new developments and look for ways to implement into current workstreams.
• Plan, manage, and track team activities, timelines, and resources.
• Responsible for hiring, development and performance management of assigned team members; ensure team alignment with other department functions.
• Resolve standard and complex issues raised by the team; escalate unprecedented issues.
• Coach and develop the team to meet their objectives and growth goals.
• Facilitate collaboration and interaction between Biostatistics and other teams (Data Management, Safety, Project Management, Monitoring, PRO, Clinical, etc.).
• Cultivates a culture of inquiry, improvement, and equity. Encourages team members to promote the NMDP values through their daily work.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Logistic regression, linear regression, survival analysis and other core statistical methods.
• Research study design principles and statistical standards for Phase I-III clinical trials.
• Scientific and therapeutic research concepts, experience in oncology a benefit.
• Advanced analytical techniques and statistical programming, with high-level proficiency in SAS (and optionally R).
• Regulatory guidance for clinical trials (e.g. ICH, FDA).

Ability to:

• Think critically.
• Lead and manage a team effectively.
• Influence colleagues and stakeholders regarding adoption of new ideas.
• Demonstrate strong oral and written communication; demonstrate public speaking effectiveness.
• Manage conflict.
• Advise senior leaders with confidence on relevant topics.
• Exhibit strong project management skills with a demonstrated ability to manage teams project milestones in a timely manner.
• Program with statistical analysis programs, e.g. SAS, R.

Education and/or Experience:

• Master's degree required. Biostatistics concentration preferred, or closely related field where statistical design and analyses comprised the primary course of study and application.
• 5+ years' experience in performing statistical design/analysis in clinical trials space.
• 2+ years experience in people leadership or equivalent experience mentoring and coaching others.
• Preference given to candidates with experience working in the pharmaceutical/medical device industry and working knowledge of CDISC standards.

Responsibilities

POSITION SUMMARY:

The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies space. This role ensures the highest quality of statistical and programming support of our hematopoietic stem cell and cellular therapy clinical trials that further the mission, vision and strategic plan of NMDP. The Manager, Biostatistics role will ensure the statistical aspects of clinical activities meet required standards and are robust and valid. This role directly oversees biostatisticians and statistical programmers including hiring, training, leading, overseeing, reviewing work and coaching for growth and development.

ACCOUNTABILITIES:

Trials oversight:

• Complete statistical design, planning and analysis duties of individual studies, as needed.
• Coordinate and oversee statistical deliverables and programming activities of CRO services clinical trials.
• Collaborate with study statisticians to provide expertise in design of clinical trials.
• Review and approve protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, datafile specifications, clinical study reports, protocol deviations, clinical publications, and other study documents or communications.
• Provide guidance on implementation of statistical analysis plans to the study biostatisticians.
• Develop and maintain statistical and programming policies, guidelines, and procedures (SOPs, training manuals, etc.).
• Develop and maintain a program to train biostatistician and statistical programmer team members, based on current needs of CRO Services portfolio and strategic direction.
• Lead standardization efforts, process improvements, and best practices for the team and contribute to cross-functional process improvement efforts.

Strategic planning:

• Define team goals and strategy on an ongoing basis, in collaboration with the Senior Manager, Biostatistics.
• Provide innovation ideas to Senior Manager, Biostatistics on improving current processes and deliverables including methodology, best practices, and process improvements to maximize biostatistics value and increase efficiency in current resources.

Functional leadership:

• Stay up to date on the latest developments in the statistics and/or programming fields and contribute to scientific advances in the field. Educate the team on new developments and look for ways to implement into current workstreams.
• Plan, manage, and track team activities, timelines, and resources.
• Responsible for hiring, development and performance management of assigned team members; ensure team alignment with other department functions.
• Resolve standard and complex issues raised by the team; escalate unprecedented issues.
• Coach and develop the team to meet their objectives and growth goals.
• Facilitate collaboration and interaction between Biostatistics and other teams (Data Management, Safety, Project Management, Monitoring, PRO, Clinical, etc.).
• Cultivates a culture of inquiry, improvement, and equity. Encourages team members to promote the NMDP values through their daily work.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Logistic regression, linear regression, survival analysis and other core statistical methods.
• Research study design principles and statistical standards for Phase I-III clinical trials.
• Scientific and therapeutic research concepts, experience in oncology a benefit.
• Advanced analytical techniques and statistical programming, with high-level proficiency in SAS (and optionally R).
• Regulatory guidance for clinical trials (e.g. ICH, FDA).

Ability to:

• Think critically.
• Lead and manage a team effectively.
• Influence colleagues and stakeholders regarding adoption of new ideas.
• Demonstrate strong oral and written communication; demonstrate public speaking effectiveness.
• Manage conflict.
• Advise senior leaders with confidence on relevant topics.
• Exhibit strong project management skills with a demonstrated ability to manage teams project milestones in a timely manner.
• Program with statistical analysis programs, e.g. SAS, R.

Education and/or Experience:

• Master's degree required. Biostatistics concentration preferred, or closely related field where statistical design and analyses comprised the primary course of study and application.
• 5+ years' experience in performing statistical design/analysis in clinical trials space.
• 2+ years experience in people leadership or equivalent experience mentoring and coaching others.
• Preference given to candidates with experience working in the pharmaceutical/medical device industry and working knowledge of CDISC standards.