Biostatistics Sr Mgr (remote or office-based)

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.

Responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, senior reviewer or project oversight on select projects. Contributes to study proposals and bids, representing the department at bid defenses. Oversees the resourcing of program of studies, or integrated summaries, develops and implements strategies to ensure optimal efficiencies around process, programming and client needs. Provides support, guidance and project leadership to junior and senior team members. Provides oversight for strategic client relationships, and/or oversight for significant client portfolios.

Essential Functions:

• Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.

• Serves as (or mentors others in the role of) the randomization statistician on selected projects.

• Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.

• Manages resourcing and delivery strategy of complex books of work - ISS/ISE, submissions etc

• Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge.

• Participates in strategic client franchise leadership.

• Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc.

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.

Responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, senior reviewer or project oversight on select projects. Contributes to study proposals and bids, representing the department at bid defenses. Oversees the resourcing of program of studies, or integrated summaries, develops and implements strategies to ensure optimal efficiencies around process, programming and client needs. Provides support, guidance and project leadership to junior and senior team members. Provides oversight for strategic client relationships, and/or oversight for significant client portfolios.

Essential Functions:

• Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.

• Serves as (or mentors others in the role of) the randomization statistician on selected projects.

• Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.

• Manages resourcing and delivery strategy of complex books of work - ISS/ISE, submissions etc

• Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge.

• Participates in strategic client franchise leadership.

• Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc.

Qualifications:

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’).

Master degree in statistics, biostatistics, mathematics or related field with 8 years experience

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Demonstrated initiative and motivation

• Capable of leading complex projects

• Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff

• Strong verbal and written communication skills

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

• In-depth knowledge of SAS® and clinical biostatistics

• In-depth understanding of the drug development process and FDA regulations

• Capable of managing change and uncertainty to optimize positive outcomes

Working Environment:

PPD values the health and wellbeing 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.)

PPD Defining Principles:

We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD-

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you!

*LI-KF1

#PPDHP

Qualifications:

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’).

Master degree in statistics, biostatistics, mathematics or related field with 8 years experience

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Demonstrated initiative and motivation

• Capable of leading complex projects

• Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff

• Strong verbal and written communication skills

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

• In-depth knowledge of SAS® and clinical biostatistics

• In-depth understanding of the drug development process and FDA regulations

• Capable of managing change and uncertainty to optimize positive outcomes

Working Environment:

PPD values the health and wellbeing 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.)

PPD Defining Principles:

We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD-

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you!

*LI-KF1

#PPDHP