Senior Biostatistician

Senior Biostatistician

Fulltime | Remote - PH Based

Role Overview

We are seeking a highly skilled Senior Biostatistician to provide statistical leadership and support for clinical studies within the pharmaceutical or biotechnology industry. In this role, you will collaborate with cross-functional teams to design studies, develop statistical analysis plans, interpret data, and contribute to regulatory submissions. The ideal candidate has strong expertise in clinical trial methodology, regulatory standards, and statistical programming, along with excellent communication and collaboration skills.

Key Responsibilities

• Provide statistical expertise and support for clinical trials and research studies.

• Contribute to the development of study protocols, including study design discussions and sample size calculations.

• Review Case Report Forms (CRFs) and data review guidelines.

• Develop and review Statistical Analysis Plans (SAPs), including analysis datasets and Tables, Listings, and Graphs (TLG) specifications.

• Perform statistical analyses and interpret study data to support clinical development.

• Prepare and contribute to clinical study reports, including integrated summaries for regulatory submissions.

• Present statistical methodologies and explain analytical decisions to cross-functional teams in clear, accessible language.

• Ensure compliance with FDA regulations, Good Clinical Practice (GCP), and guidelines for electronic regulatory submissions.

• Contribute to the development, documentation, validation, and maintenance of statistical programming standards, tools, and macros.

• Support the development of CRFs, edit check specifications, and data validation plans.

• Review and/or author data transfer specifications for external vendor data.

• Collaborate with internal teams and external partners such as CROs, software vendors, and clinical development teams to meet project timelines and objectives.

• Review and/or develop Standard Operating Procedures (SOPs) and Work Instructions related to statistical programming practices.

Qualifications

• Master’s degree in Statistics, Biostatistics, or a related discipline (PhD strongly preferred).

• 5+ years of experience supporting clinical trials in the pharmaceutical or biotechnology industry.

• Experience working with a Contract Research Organization (CRO) is highly preferred.

• Experience in oncology clinical trials is a plus.

• Strong experience in sample size calculations, protocol development, statistical analysis plans, and clinical study reports, including integrated summaries for regulatory submissions.

• Proficiency in SAS programming, particularly for QC of critical outputs and generating efficacy and safety tables.

• Working knowledge of R programming is a plus.

• Strong understanding and implementation of CDISC standards for regulatory submissions.

• Experience in ADaM dataset specification and quality control.

• Ability to build strong relationships and collaborate effectively with regional or global teams.

• Excellent communication skills, with the ability to clearly explain statistical methodologies and implications to both technical and non-technical audiences.

Remote work readiness, including a stable internet connection with minimum 100 Mbps speed.