Director, Programming/ Statistics (remote or office-based)

Pharmaceutical Product Development (PPD)

NC-Wilmington-Wilmington NC HQ


Submission for the position: Director, Programming/ Statistics (remote or office-based) - (Job Number: 184660)

PPD’s mission is to improve health. It starts as an idea to find a 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 our talented, bright and energetic teams.

We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

In this role, you will serve as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

What will you do in this role?

Provideoperational leadership for the department. Evaluates workloads, resources, processes, and technologies for efficient operation of the department. Ensures systems are in place to produce quality work efficiently, allowing for continual growth of department. Consults with project teams, sponsors, and other clients/agencies on project-related issues. Acts as the Senior Reviewer or project oversight on multiple projects.

Essential Functions and Other Job Information:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific, ethical, and regulatory standards.

• Acts as senior reviewer on multiple projcts, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.

• Serve in the a project oversight role management role of Project Oversight for studies to represent the study(s) to all functions as needed, with client, and fully accountable for all aspects of the management of risk.

• Informs senior leaders of department activities, accomplishments, and needs.

• Participates in long-range strategic planning, development of departmental business plan, and departmental budget.

• Prepares bids, for marketing, and business development.

• Communicates company and department policies and priorities to department staff and assuring compliance.

• Ensures appropriate personnel resources are applied to department projects based on priorities and relative complexity.

• Provides statistical consultation and serves as senior reviewer on projects.

• Reviews and/or approves documents related to project activities.

•Participates in project development and FDA meetings concerning investigational and marketed drugs assigned to the department.

PPD’s mission is to improve health. It starts as an idea to find a 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 our talented, bright and energetic teams.

We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

In this role, you will serve as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

What will you do in this role?

Provideoperational leadership for the department. Evaluates workloads, resources, processes, and technologies for efficient operation of the department. Ensures systems are in place to produce quality work efficiently, allowing for continual growth of department. Consults with project teams, sponsors, and other clients/agencies on project-related issues. Acts as the Senior Reviewer or project oversight on multiple projects.

Essential Functions and Other Job Information:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific, ethical, and regulatory standards.

• Acts as senior reviewer on multiple projcts, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.

• Serve in the a project oversight role management role of Project Oversight for studies to represent the study(s) to all functions as needed, with client, and fully accountable for all aspects of the management of risk.

• Informs senior leaders of department activities, accomplishments, and needs.

• Participates in long-range strategic planning, development of departmental business plan, and departmental budget.

• Prepares bids, for marketing, and business development.

• Communicates company and department policies and priorities to department staff and assuring compliance.

• Ensures appropriate personnel resources are applied to department projects based on priorities and relative complexity.

• Provides statistical consultation and serves as senior reviewer on projects.

• Reviews and/or approves documents related to project activities.

•Participates in project development and FDA meetings concerning investigational and marketed drugs assigned to the department.

Education and Experience:

Masters degree in statistics, biostatistics, mathematics or related field with 10 Masters experience,

preferring at least 12 years of leadership experience or at least 14 years with only a Bachelors degree

Previous experience that provides the knowledge, skills, and abilities to perform the job

5 years of management responsibility

Strong leadership skills

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:

• Capable of effectively mentoring senior staff/managers to direct and promote teamwork in a multidisciplinary

team setting

• Superior management skills, as shown through management of multiple projects and proven ability to

manage, mentor, and motivate staff

• Demonstrated initiative and motivation

• Superior written and verbal communications skills, including proficiency in the English language

• Positive attitude and the ability to work well with others

• Capable of supervising, evaluating, and mentoring departmental personnel

• Capable of delegating tasks and facilitating the completion of assignments

• Capable of driving innovation in developing new ideas related to process improvements

• Comprehensive organizational, judgment, analytical, decision-making and interpersonal skills

• Capable of independently assessing sponsor needs and working with project team members in

producing compliant deliverables

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

Education and Experience:

Masters degree in statistics, biostatistics, mathematics or related field with 10 Masters experience,

preferring at least 12 years of leadership experience or at least 14 years with only a Bachelors degree

Previous experience that provides the knowledge, skills, and abilities to perform the job

5 years of management responsibility

Strong leadership skills

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:

• Capable of effectively mentoring senior staff/managers to direct and promote teamwork in a multidisciplinary

team setting

• Superior management skills, as shown through management of multiple projects and proven ability to

manage, mentor, and motivate staff

• Demonstrated initiative and motivation

• Superior written and verbal communications skills, including proficiency in the English language

• Positive attitude and the ability to work well with others

• Capable of supervising, evaluating, and mentoring departmental personnel

• Capable of delegating tasks and facilitating the completion of assignments

• Capable of driving innovation in developing new ideas related to process improvements

• Comprehensive organizational, judgment, analytical, decision-making and interpersonal skills

• Capable of independently assessing sponsor needs and working with project team members in

producing compliant deliverables

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 Submission for the position: Director, Programming/ Statistics (remote or office-based) - (Job Number: 184660)


2021-02-22 00:00:00


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