Principal Biostatistician FSP

JOB DESCRIPTION

Who Are You?

As a Principal Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more post-marketing studies.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician, you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

Position Overview:

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials, offering expertise in processes, clinical development plans, concept sheets, and protocols. They may also oversee work supported by other vendors. You will formulate an integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights, and automate processes to reduce effort and time for repeated use.

Responsibilities:

• Participate in the development of study protocols, including study design discussions and sample size calculations.
• Review CRFs and data review guidelines; develop statistical analysis plans (SAPs), including analysis datasets and TLG specifications.
• Perform statistical analyses.
• Interpret statistical results.
• Prepare and review study reports.
• Lead study activities when called upon.
• Utilize strong communication skills to present and explain methodology and decisions in lay terms.
• Serve as a team player, with a willingness to go the extra mile to achieve results and meet deadlines.
• Be adaptable and flexible when priorities change.

Qualifications:

• Master’s degree in statistics or a related discipline; PhD strongly desired.
• 8-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry; experience in a CRO is strongly desired.
• 3-5 years of Study Lead experience with cross-functional teams.
• Experience in sample size calculation, protocol concept and development, SAP, and clinical study reports including integrated summaries for submissions.
• Experience with Real-World Data/RWD (especially OMOP data)required.
• Experience with oncology clinical studiesrequired.
• Knowledge and implementation of advanced statistical methods.
• Good SAS programming skills for QCing critical outputs, efficacy/safety tables, and collaboration with programmers. Knowledge of R programming is a plus.
• Strong knowledge of ICH guidelines.
• Solid understanding and implementation of CDISC requirements for regulatory submissions.
• Adept at generating ADaM specifications and programmatic review of datasets.
• Experience with submissions (ISS/ISE) is strongly desired.
• Effective communicator: able to explain methodology and decision consequences in lay terms.
• Team player; willing to go the extra mile to achieve results and meet deadlines.
• Flexible when priorities change and capable of dealing with ambiguity.

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