Sr Mgr Biostatistics (remote)

PPD’s mission is to improve health.

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you!

We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.

As a Senior Manager, Biostatistics, you will have a key management role to grow and development your team.

Serves as management oversight on broad-based projects, such as NDA projects or complex, multi-protocol programs. Performs management functions relating to the administrative and scientific activities of multiple projects, as well as line manage supervisory statistics staff. Coordinates projects across multiple locations. Provides leadership and identify and initiate division process-improvement activities in collaboration with other division management. Assists Director/Associate Director in training and advancement of staff. Directly contributes to study proposals and bids, representing the Biostatistics and Programming department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies. Provides Biostatistics oversight for strategic client relationships, and/or oversight for significant client portfolios.

Essential Functions Serves as lead statistician on large scale/complex projects. Oversees the project work of directly reporting statisticians. Provides technical expertise and guidance in the development of protocols, analysis plans, programming specifications, interpretation, and writing of results. Acts as a senior statistical reviewer commensurate with expertise and ability. Provides first level of PPD management communication with clients. Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management. Provides budgetary reconciliation against actual expenditure. Identifies and quantifies the budget and expense differences. Ensures the effective resource and utilization management of staff. Recruits, trains and develops employees. Ensure SOP and FDA guideline adherence. Leads departmental management in process-improvement strategies. Prepares proposals and participates in business development presentations. Engages in raining and professional development Provides line management of staff. Participates in strategic client franchise leadership.

PPD’s mission is to improve health.

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you!

We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.

As a Senior Manager, Biostatistics, you will have a key management role to grow and development your team.

Serves as management oversight on broad-based projects, such as NDA projects or complex, multi-protocol programs. Performs management functions relating to the administrative and scientific activities of multiple projects, as well as line manage supervisory statistics staff. Coordinates projects across multiple locations. Provides leadership and identify and initiate division process-improvement activities in collaboration with other division management. Assists Director/Associate Director in training and advancement of staff. Directly contributes to study proposals and bids, representing the Biostatistics and Programming department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies. Provides Biostatistics oversight for strategic client relationships, and/or oversight for significant client portfolios.

Essential Functions Serves as lead statistician on large scale/complex projects. Oversees the project work of directly reporting statisticians. Provides technical expertise and guidance in the development of protocols, analysis plans, programming specifications, interpretation, and writing of results. Acts as a senior statistical reviewer commensurate with expertise and ability. Provides first level of PPD management communication with clients. Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management. Provides budgetary reconciliation against actual expenditure. Identifies and quantifies the budget and expense differences. Ensures the effective resource and utilization management of staff. Recruits, trains and develops employees. Ensure SOP and FDA guideline adherence. Leads departmental management in process-improvement strategies. Prepares proposals and participates in business development presentations. Engages in raining and professional development Provides line management of staff. Participates in strategic client franchise leadership.

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years) or equivalent and relevant combination of education, training, and experience.

Prefer MA/MS degree in statistics, biostatistics, mathematics, or related field with appropriate statistical coursework and 6 years of experience; With a Ph.D., 4 years of experience.2 years clinical trials experience2 years of management responsibility

Knowledge, Skills and Abilities:

Demonstrated initiative and motivation

Proven performance in leading complex projectsEvidence of strong staff management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff

Proven success in the line management of supervisory staff

Excellent verbal and written communication skills

Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting

Strong knowledge of SAS® and clinical biostatisticsDemonstrated knowledge of the drug development process and FDA regulations

Demonstrated ability to manage change and uncertainty to optimize positive outcomes

Management Role:

Manager role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent, multi-year successful performance. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details).

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years) or equivalent and relevant combination of education, training, and experience.

Prefer MA/MS degree in statistics, biostatistics, mathematics, or related field with appropriate statistical coursework and 6 years of experience; With a Ph.D., 4 years of experience.2 years clinical trials experience2 years of management responsibility

Knowledge, Skills and Abilities:

Demonstrated initiative and motivation

Proven performance in leading complex projectsEvidence of strong staff management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff

Proven success in the line management of supervisory staff

Excellent verbal and written communication skills

Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting

Strong knowledge of SAS® and clinical biostatisticsDemonstrated knowledge of the drug development process and FDA regulations

Demonstrated ability to manage change and uncertainty to optimize positive outcomes

Management Role:

Manager role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent, multi-year successful performance. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details).