Senior Biostatistician

JOB OVERVIEW

The Senior Biostatistician is responsible for the overall statistical management of services for projects to assure high quality and on-time delivery in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. Provides leadership and statistical expertise into clinical development plans, concepts, and protocols as well as conducts statistical analysis and validates and

interprets statistical analysis results.

JOB RESPONSIBILITIES

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent company and the statistical team on the Product Development Teams of sponsors. Provide oversight of statistical analysis plans, statistical outputs, and other documents as required.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
• Contribute to the development of sourcing strategy for projects.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Master's degree in Statistics, Biostatistics, or related discipline. Ph.D. preferred.
• 4-8 years experience in statistical or biostatistical analysis supporting clinical trial operations for drug development in the pharma/biotech industry
• Must have experience in writing statistical plan using SAP
• 3+ years working knowledge of SAS and/or R programming languages (combined)
• Study Lead experience working with cross-functional teams. Experience leading global teams a plus.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
• Solid understanding & implementation of CDISC requirement for regulatory submissions.
• Adept in ADaM specifications generation and review of datasets.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with advanced, complex statistical methods that apply to applicable clinical trials.