PPD

Biostatistics Mgr - EMEA - Home-based (Europe)

1 day left

Company
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Posted
14 May 2021
Closes
13 Jun 2021
Ref
1190885
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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 & Programming 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 level Biostatistician to join our Biostatistics & Programming department in EMEA as a Bios Mgr. Responsibilities include:

  • 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.


Qualifications:

To be considered for the role you should have the following qualifications and experience:

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7+ years').
  • Master's degree in statistics, biostatistics, mathematics or related field with 7+ years experience
  • 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 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.  

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