[Hiring] Senior Biostatistician @StratifyIQ

Role Description

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.

• 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.