Principal Biostatistician

Key Skills

Agile methodologies, Biostatistics, Effective communication skills, Google Cloud Platform (GCP), R Programming, SAP, SAS, Statistical modeling

Job Description

RESPONSIBILITIES

• Perform/oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to Sponsor, regulatory authorities, and the scientific community.
• Provide oversight of statistical analysis plans, statistical outputs, and other documents as required.
• Represent company and the statistical team on the Product Development Teams of sponsors. 
• Provide statistical and methodological consultation on special statistical methodology or statistical, scientific, and regulatory issues.
• Collaborate with medical monitors and other study personnel on the creation of clinical trial designs.
• Perform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a design.
• Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements.
• Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by statistical programmers.
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
• Key contributor in project planning.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management. 
• Manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
• Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Master's degree in Statistics, Biostatistics, or related discipline. Ph.D. preferred.
• 10+ with Master’s/7+ with PhD years’ experience in statistical or biostatistical analysis supporting clinical trial operations for drug development in the pharma/biotech industry
• Proficiency working knowledge of SAS and/or R programming languages 
• 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.
• Knowledge of FDA regulations, ICH GCP guidelines, the drug development process

PREFERRED SKILLS

• Energized self-starter
• Excellent organizational skills
• Excellent communication skills, verbal and written
• Exceptional attention to detail
• Strong interpersonal skills work within a cross-functional team
• Excellent problem-solving skills
• Effective decision maker – able to exercise good judgment and take appropriate action independently
• Flexible, team player
• Proven ability to organize and effectively prioritize workload and deliverables