Principal Biostatistician, Fsp

5 months ago

Cambridge, United Kingdom Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**Who is PPD Clinical Research Services?**

PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is toenable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.

**The PPD FSP Solution**:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

**Principal Biostatistician, FSP (Client-dedicated) - Home based, EMEA**

We are looking for Principal Biostatisticians who implement diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on handling the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality. You 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.

**Key Accountabilities/Responsibilities**:
The Principal Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:

- Serves as the responsible biostatistician on Phase I to III clinical trials, ranging from 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.
- Oversight of project financials.
- Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
- Contributes to press releases and scientific papers.

Skills and Experience:

- Master’s degree in statistics or biostatistics required.
- Minimum of 6-8 years of biostatistical experience, plus lead statistician experience.
- Experience in handling CROs and vendors.
- Experience with Data Monitoring Committees (DMC's)
- Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
- Proficient with other statistical software such as R, EAST, Winbugs is a plus.
- Detailed 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 proven leadership ability.
- Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.

**Physical Requirements / Work Environment**

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgroun

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