Job Description

We are seeking independent thinkers with problem-solving skills and a quality focused mindset to join our award-winning and supportive global team on an exciting clinical research adventure. The PPD Biostatistics & Programming environment is structured to ensure focus and development in key areas of interest. Our working model revolutionizes delivery through aligned and focused pillars which drive in-depth knowledge and enhanced coaching. We offer continued career advancement opportunities and comprehensive training to help you reach your full potential and develop your own unique career path within PPD, part of Thermo Fisher Scientific At Thermo Fisher Scientific, you\xe2\x80\x99ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on \xe2\x80\x93 now and in the future. 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: As a Principal Biostatistician, you will serve as a lead in providing statistical, process and regulatory knowledge to the department. You will function as the lead statistician and project lead on complex projects and as senior reviewer with additional oversight as needed on complex or highly complex studies. In the Principal role, you will serve as a subject matter expert on statistical knowledge and clinical trial related topics, as well as providing mentorship to junior team members. 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, and budget 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\xe2\x80\x99). 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\xc2\xae 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 member