Principal Biostatistician- Real World Evidence(RWE)-Remote @ Canada

at  ClinChoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…ClinChoice is searching for a Principal Biostatistician Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

JOB DESCRIPTION

As a Principal Biostatistician, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may lead to innovative medical breakthroughs.
You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatments and improving global well-being.
The Principal Biostatistician will perform sophisticated scientific statistical analyses in support of the company’s Global Medicines Development and Affairs area on new and complex issues. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

GENERAL SUMMARY:

The Principal Biostatistician will perform advanced scientific statistical analyses in support of the company’s Global Medicines Development and Affairs area with some guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

KNOWLEDGE AND SKILLS:

• In-depth experience with SAS and R statistical software
• Demonstrated understanding of advanced statistical methods used in drug development
• Ability to show critical thinking with logical problem-solving
• Excellent written and verbal communication skills
• Excels in a team environment
• Collaborates well with non-statisticians

EDUCATION AND EXPERIENCE:

• Ph. D. in Statistics, Biostatistics or similarly relevant field.
• Typically requires 3 years of industry experience with a Ph.D.

• Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including the design, development and execution of the technical/statistical infrastructure.
• Possesses an advanced understanding of modern drug discovery and development processes.
• Represents Biostatistics as a member of clinical trial teams, providing input and technical guidance to elicit meaningful and/or productive outcomes.
• With minimal guidance, authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.
• Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.
• Contributes to external interactions with regulators, payers, review boards, etc.
• Develops statistical section of protocols, including sample size estimates and randomization plans.
• Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review.
• Implements design and analysis methods at the study level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
• Contributes to departmental working group efforts on various advanced technical and operational issues.
• Undertakes new and complex issues with minimal guidance
• Completes assigned work in a resourceful, self-sufficient manner and creates alternative approaches to achieve desired results if needed.
• Develops breadth of knowledge across related disciplines with a drug developer mindset.