Principal Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Providing statistical support for clinical studies, particularly focusing on Hypertension;

• Contributing to the creation of study protocols, which includes engaging in discussions regarding study design and calculating sample sizes;

• Reviewing case report forms (CRFs) and data review guidelines; crafting statistical analysis plans (SAPs), which encompass specifications for analysis datasets and TLGs;

• Conducting statistical analyses;

• Interpreting the results of statistical analyses;

• Compiling clinical study reports, including integrated summaries for regulatory submissions;

• Leading study-related activities when necessary;

• Leveraging your strong communication abilities to present and clarify methodologies and the implications of decisions in simple terms;

• Acting as a collaborative team member, demonstrating a readiness to go the extra mile to achieve results and meet deadlines;

• Maintaining adaptability and flexibility in response to shifting priorities.

⛳️ Requirements

• Master’s degree in statistics or a related field. A PhD is highly preferred.

• Over 5 years of experience supporting clinical trials within the Pharmaceutical or Biotechnology sectors. Experience in a Contract Research Organization (CRO) is strongly preferred.

• Proficiency in sample size calculation, protocol concept development, protocol formulation, SAP creation, and preparing clinical study reports, including integrated summaries for submissions.

• Familiarity with advanced statistical methods and their application.

• Competence in SAS and R programming for quality control of critical outputs, efficacy/safety tables, and collaboration with programmers. Knowledge of R programming is an advantage.

• Strong understanding of ICH guidelines.

• Comprehensive knowledge and application of CDISC requirements for regulatory submissions.

• Skilled in generating ADaM specifications and performing quality control on datasets.

• Experience with submissions.

• Background in working with cross-functional teams, including a Study Management Team (SMT) or similar teams for various clients.

• Effective communication skills: capable of articulating methodologies and the implications of decisions in easily understandable terms.

• A team-oriented individual; eager to put in the extra effort to achieve results and meet deadlines.

• Ability to remain flexible when priorities shift and to navigate through ambiguity.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and growth.

• Collaborative and supportive work environment.

• Flexible work arrangements.