Remote Principal Biostatistician

Placements24; East London; Hybrid; ZAR 2,449,000 - 3,428,000; Full time

Benefits offered by this job

High salary

Bonus structure

Health insurance

Generous paid time off

Remote work with support

Job summary

Placements24 seeks a Principal Biostatistician to join its fully remote team. The role designs statistical methodologies for clinical trials and research studies, ensuring robust data analysis and regulatory alignment.

You will lead complex analyses, mentor junior statisticians, and collaborate with cross-functional teams worldwide. A PhD and 10+ years in biostatistics within pharma/biotech are expected, with expertise in adaptive designs, Bayesian methods, and SAS/R.

Qualifications

• PhD in Biostatistics, Statistics or closely related field.
• 10+ years in biostatistics in pharma/biotech with senior/leadership experience.
• Expertise in adaptive designs and Bayesian methods for trials.
• Proficiency with SAS, R, or S-Plus.
• Strong regulatory knowledge (ICH, FDA).

Responsibilities

• Design statistical analysis plans for trials and studies per objectives and regs.
• Develop and validate statistical methods for complex datasets.
• Provide statistical guidance to cross-functional teams.
• Lead statistical aspects of regulatory submissions and liaise with agencies.
• Mentor junior biostatisticians and develop their skills.
• Stay updated on new methodologies and tools and promote their use.

Skills

Biostatistics leadership

Adaptive designs

Bayesian methods

SAS

R

S-Plus

Regulatory awareness (ICH/FDA)

Communication

Leadership

Education

PhD in Biostatistics or related

Tools

SAS

R

S-Plus

Job description

About the Role

Our client is seeking a highly experienced and influential Principal Biostatistician to join their fully remote team. This senior role will be instrumental in designing statistical methodologies for clinical trials and research studies, ensuring the integrity and validity of data analysis. You will provide statistical expertise, lead complex analytical projects, and mentor junior biostatisticians. The ideal candidate is a visionary leader with a deep understanding of statistical principles and their application in healthcare and pharmaceutical research, contributing to significant advancements from anywhere in the world.

Key Responsibilities

• Design statistical analysis plans for clinical trials and research studies, ensuring alignment with study objectives and regulatory requirements.
• Develop, implement, and validate statistical methods for analyzing complex datasets from various research programs.
• Provide statistical expertise and guidance to cross-functional teams, including clinical operations, data management, and regulatory affairs.
• Lead the statistical aspects of regulatory submissions and interact with regulatory agencies as needed.
• Mentor and train junior biostatisticians, fostering their technical and professional development.
• Stay abreast of emerging statistical methodologies and computational tools, and champion their appropriate use within the organization.

Requirements

• Ph.D. in Biostatistics, Statistics, or a closely related quantitative field.
• 10+ years of progressive experience in biostatistics within the pharmaceutical or biotechnology industry, with a significant portion in a senior or leadership capacity.
• Expertise in statistical methodologies for clinical trial design (e.g., adaptive designs, Bayesian methods) and analysis.
• Proficiency in statistical software packages such as SAS, R, or S-Plus.
• Strong understanding of regulatory guidelines (e.g., ICH, FDA) pertinent to pharmaceutical development.
• Excellent communication, leadership, and problem-solving skills, suitable for a remote work environment.

Benefits

• Exceptional salary and bonus structure commensurate with seniority.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and professional development budget.
• Flexible remote work environment with full technical and administrative support.
• Opportunity to lead high-impact statistical initiatives and shape the future of clinical research.