Senior Biostatistician - Senior Manager, Biostatistics

RESPONSIBILITIES :

• Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios
• Perform sample size calculations and write statistical methodology sections for inclusion in study protocols
• Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
• Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions
• Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable
• Develop SAS programs to produce and / or QC statistical tables / figures / data listings
• Perform mapping from raw datasets to CDISC SDTM datasets
• Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission
• Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data
• Review and / or write the statistical and results sections of clinical study reports
• Review and / or assist in writing publications
• Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
• Manage multiple projects
• Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review
• Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis
• Support proposal development and attend bid defense meetings
• Review Request for Proposal (RFP) and Scope of Work (SOW) documents
• Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks
• Manage project budget and forecast resources needed for studies
• Additional responsibilities as assigned by supervisor / manager

EDUCATION

• Master’s degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline required
• PhD degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred

EXPERIENCE

• Minimum of 5 years of experience in statistical analysis of clinical trials data or
• Minimum of 3 years of experience in statistical analysis of clinical trials data if relevant PhD degree has been obtained

SKILLS

• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods
• Proficiency in SAS statistical programming
• Knowledge of other statistical and data management software packages is a plus
• Strong written and oral communication skills
• Knowledge and experience with CDISC data standards and models
• Strong project management and mentoring / leadership skills
• In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Ability to effectively manage multiple tasks and projects
• Ability to clearly describe statistical techniques and interpret results

Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception / clarity and muscle control / coordination.

This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.