Thermo Fisher Scientific
Thermo Fisher Scientific Italy Italy
3 months ago
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health (https://www.ppdi.com/about/purpose-mission-strategy) . You will be joining a truly collaborative and winning culture (https://www.ppdi.com/careers/about/culture) as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
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 Biostatistics Manager, you will be responsible for the statistical aspects of clinical trials from design through analysis and reporting, including... client or regulatory interactions.
• Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, or senior reviewer 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) randomization statistician on selected projects.
• 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.
• Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives.
• Provides expert knowledge and mentoring on statistical and regulatory issues, development/delivery of training, and implementation of best practices for the department.
• Serves as senior reviewer on moderate or complex studies as assigned.
• Interacts with sponsor counterparts or leadership, and/or other departments including contractual negotiations.
• Provides technical input/writing into study design and statistical considerations during protocol development or review, SAP development/review, and provides expert knowledge and experience of complex trials design across different therapeutic areas.
• Leads the preparation and review of key submission deliverables such as CSRs, ISS, ISE, Reviewers Guides, etc.
• Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc.
Education and Experience:
• Master degree in statistics, biostatistics, mathematics or related field with 7+ 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
• Strong knowledge of SAS® and clinical biostatistics
• Strong understanding of the drug development process and FDA regulations
• Capable of managing change and uncertainty to optimize positive outcomes
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 (https://www.ppdi.com/careers/about#Training) , 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 (https://www.ppdi.com/careers/life-at-ppd) , 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!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status
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