Biostatistician

Description:

Precision Medicine Group is seeking a Biostatistician II to provide comprehensive statistical support across all phases of clinical development. This role involves designing and reviewing statistical sections of clinical protocols, authoring statistical analysis plans, generating randomization schedules, and developing SAS programs for data analysis and reporting. You will be responsible for creating tables, figures, listings, and analysis datasets according to company and regulatory guidelines.

Key responsibilities include:

• Generating randomization schedules and verifying sample size calculations.

• Writing statistical analysis plans with table, figure, and listing shells.

• Performing statistical analyses, data transformations, and advanced statistical modeling using SAS.

• Conducting quality control of statistical programs, reports, and presentations.

• Providing statistical analysis for regulatory submissions and Data Monitoring Committees (DMCs).

• Reviewing statistical sections of clinical study reports and collaborating with sponsors, project managers, and external vendors.

• Mentoring new biostatisticians and contributing to bid defense meetings.

Candidates should possess strong understanding of statistical concepts (hypothesis testing, regression, survival analysis, non-parametric methods, estimation), clinical trial methodologies (randomization, sample size estimation), and relevant industry standards (ICH guidelines, CDISC, FDA guidelines, 21 CFR Part 11).

This role demands excellent communication, problem-solving, and organizational skills, along with experience in SAS programming and statistical analysis for clinical trials. Oncology and rare disease experience is preferred.