As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Who is PPD Clinical Research Services?

PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

Summarized Purpose:

• Serves 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.
• Acts as a project manager, overseeing the statistical and programming aspects of clinical trials from design, through analysis and reporting, acting as the lead statistician on multiple projects.
• Represents the department within the company and with interactions with client companies and regulatory agencies, on simple to complex study design matters, directly contributing to complex study proposals and bids, representing the department at bid defenses.
• Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.

Essential Functions:

• Provides expert knowledge within the department on statistical and regulatory issues, mentors members of the department and provides project guidance and statistical advice.
• Provides expert knowledge and experience of complex trials design across different therapeutic areas.
• Provides expertise in the development and delivery of training material, and the implementation of departmental procedures for the team. Contributes to process improvement and departmental initiatives.
• Serves as senior reviewer on simple or moderately complex studies as assigned with minimal oversight, and on more complex studies as assigned with supervision as needed.
• Serves as a lead statistician on multiple projects and leads project teams for multiple protocols. Conducts team meetings, maintains project timelines, assesses resource need, provides resources, andbudget management. Ensures that SOPs are being followed and that appropriate project documentation is ongoing.
• Provides management with timely, accurate status and resourcing reports. Allocates and coordinates resources within the team to achieve timelines, time management of own and team's time spent on projects.
• Interacts with the sponsor on statistical aspects of the project and present at meetings as required.
• Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.
• Leads the development and review of statistical analysis plans, including table, listing and graph specifications. Organizes the production of statistical analyses and statistical appendices, with appropriate documentation. Ensures that appropriate validation for statistical analyses and statistical appendices is implemented.
• Specifies the general structure of the analysis database, oversees its development, and ensures completeness for use in all programming.
• Oversees the preparation and quality review of statistical reports, integrated summaries of safety, integrated summaries of efficacy and other documents, as required. Contributes statistical methods section for integrated clinical statistical reports.
• Provides input to management as to hiring recommendations, department policies, and resourcing requirements.
• Acts as the representative of the department to other divisions.
• Assists in bidding and business development activities, as required.

Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years’).
• Master's degree in statistics, biostatistics, mathematics or related field
• Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage.
• 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:

• Excellent understanding of the statistical principles underlying clinical trials
• Excellent statistical skills
• Excellent understanding of the regulatory issues associated with the reporting of clinical data in the submission process
• Great consultative skills
• Outstanding SAS® programming skills and familiarity of other statistical packages ( eg StatXact, Nquery) and understanding of database structures
• Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Capable of adapting and adjusting to changing priorities
• Excellent written and verbal communication skills, including proficiency in the English language
• Capable of working in a multi-disciplinary team setting
• Demonstrated initiative, motivation and problem- solving skills
• Positive attitude and the ability to organise a team and work well with others
• Good mentoring skills as shown by leadership of multiple projects and team members

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!