Senior Principal, Biostatistics | Ridgewood, NJ

Overview
A retained search is underway for a senior biostatistics leader to drive statistical strategy across clinical development programs, from protocol design through regulatory submission and study reporting. This role sits at the center of scientific rigor, regulatory alignment, and cross-functional execution.

Compensation: $190K+

Key Responsibilities

• Lead statistical strategy across clinical trials from design through final study report

• Define study design, including sample size, endpoints, and analysis methodology

• Oversee SAPs, TFL shells, and analysis dataset specifications

• Partner with data management and programming to ensure data quality and integrity

• Support regulatory submissions and health authority interactions

• Oversee CRO statisticians and programming teams to ensure quality and timelines

Ideal Candidate Profile

• Advanced degree in Statistics or Biostatistics

• Experience leading statistical activities within pharmaceutical or CRO settings

• Deep knowledge of regulatory frameworks and clinical data standards

• Strong cross-functional leadership and stakeholder management capabilities

Must Have

• PhD or MS in Statistics or Biostatistics

• Minimum of 4 years (PhD) or 6 years (MS) experience in pharmaceutical or CRO environments

• Advanced proficiency in SAS

• Strong knowledge of ICH guidelines, FDA requirements, and CDISC data structures

• Demonstrated ability to manage priorities and meet deadlines in complex environments

• Excellent communication and interpersonal skills

• Ability to operate independently and solve complex problems

• Experience leading and guiding CRO statisticians and statistical programmers