Senior Biostatistician I/II - Sponsor Dedicated (home based) - Europe - £/€7,000 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 Sr Biostatistician I/II to join our Biostatistics department working dedicated to one of our Biotech clients in EMEA. The Sr Biostatistician will work directly with the client as part of their team. Will execute diverse statistical tasks supporting the clinical development programs within the client setting. The tasks mainly focus on managing the statistical activities performed by the biostatistics CRO and on guaranteeing by means of thorough review outstanding statistical quality. Will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR
- Serves as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
- Contributes to clinical study synopses and protocols.
- Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
- Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
- Provides relevant input in the development and review of CRFs.
- Performs lead review and sets up internal QC of TFLs.
- Performs critical review of derived datasets specifications and derived datasets (ADaM).
- Contributes to clinical study reports.
- Reviews simple to complex randomization specifications and dummy randomization schemes.
- Participates in bid defense meetings.
- Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
- Contributes to press releases and scientific papers
To be considered for the role you should have the following qualifications and experience:
- Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
- Fluent with other statistical software such as R, EAST, Winbugs is a plus.
- Thorough knowledge of and experience with CDISC standards is desired.
- Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
- Displays excellent communication skills with demonstrated leadership ability.
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
- Master’s degree in statistics or biostatistics required
- Minimum of 6 years of biostatistical experience desired.
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or oncology clinical study background is a plus
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.