Sr Manager, Biostatistics - 15K (remote Or Office)

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.

As a Sr MGR Biostats, you will manage a team of senior staff and/or managers within the department who are responsible for all statistical aspects of clinical trials.

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.

Summarized Purpose:

Manages a team within the department who are 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. Organizes teams and implements strategies to ensure smooth operation and project financial success. Provides oversight for strategic client relationships, and/or oversight for significant client portfolios.

Essential Functions:

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. Ensures the effective resource and utilization management of staff.

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

Serves as the randomization statistician on selected projects. Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Reviews protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.

Prepares and reviews statistical reports, 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.

Communicates with sponsors concerning project work scope and budgetary changes after Reviewing with management.

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

Education and Experience:

Masters degree in statistics, biostatistics, mathematics or related field with 7+ years experience, preferring at least 8 years of clinical trial experience as a statistician

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

2+ yrs of management responsibility 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 including proficiency in the English language

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

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.

Work Environment:

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).

PPD Defining Principals:

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!

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• LI-remote

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