Principal Biostatistician - Home based, Europe ***€5,000 Joining bonus***
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our Biostatistics department 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.
We are currently recruiting for an experienced Principal Biostatistician to join our Biostatistics department in EMEA, working fully remotely or at one of our offices in the UK. Responsibilities of a Prin Biostatistician include:
Qualifications: Education and Experience:
- Provides expert knowledge and mentoring on statistical and regulatory issues, development/delivery of training, and implementation of best practices for the department.
- Serves as (or mentors/coordinates staff in the roles of) the lead statistician or project lead, overseeing multiple or large scale projects, ensuring adherence to company SOPs and working practices.
- Serves as senior reviewer on studies as assigned with minimal oversight
- May serve in a project oversight role for studies to represent the study(s) to all functions as needed, and fully accountable for all aspects of the management of risk.
- Interacts with sponsor counterparts or leadership, and/or other departments on status or topics related to the study(s) they are leading or overseeing. These topics can include but are not limited to timelines, quality, and cost subject matter.
- 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.
- As assigned, oversees the preparation and review of key submission deliverables such as CSRs, ISS, ISE, Reviewers Guides, etc.
- Provides input and assistance to management for activities such as hiring recommendations, department policy development/review/training, process improvement initiatives, etc.
- Contributes to the identification and development of department documents or policies, input into SOP/WPD development and revision, developing of training material and/or overseeing the training new employees.
- Leads/accountable for bidding and business development activities for standalone opportunities and contributes significantly to full-service bids/proposals/budget revision and defense strategies.
Knowledge, Skills and Abilities:
- Master degree in statistics, biostatistics, mathematics or related field with 7+ years experience
- 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.
- Experience managing multiple projects simultaneously
- Previous CRO experience is essential
- Mastery of the statistical principles underlying clinical trials
- Outstanding statistical skills
- Mastery of the regulatory issues associated with the reporting of clinical data in the submission process
- Excellent consultative skills
- Mastery of SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures
- Superb 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
- Excellent mentoring skills as shown by leadership of multiple projects and team members
At PPD we hire the best, develop ourselves and each other, and recognise 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 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 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 organisation but with a local feel.
- 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.