Biostatistician II

Job Description

Position Summary:
Provide statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.

Essential functions of the job include but are not limited to:

• Generate randomization schedules
• Assist with statistical methods review of the clinical study protocol under close supervision of senior biostatistician or above
• Provide and/or verify sample size calculations
• Provide input into development of case report forms (CRFs)
• Author statistical analysis plans, including development of table, figure and listing shells
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide programming support and assist with statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Assist with statistical consulting tasks under close supervision of senior lead biostatistician or above
• Review output across programs to ensure consistency under close supervision of senior biostatistician
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician under close supervision of senior biostatistician
• Review statistical sections of clinical study reports
• Work directly with sponsors, project managers, and external vendors on statistics-related project components
• Interact directly with study team
• Interact directly with sponsors
• Assist with completion of statistical activities for study within timelines
• Provide units for development of monthly project invoices
• Train and mentor new biostatisticians
• Assist with bid defense meetings
• Other duties as assigned

Qualifications:
Minimum Required:
Master's degree or equivalent in Statistics, Biostatistics, or related field with 2+ years experience; PhD degree in Statistics, Biostatistics, or related field
Other Required:

• Experience with SAS
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

Preferred:

• Experience with Oncology and rare disease

Skills:

• Understanding of statistical concepts and techniques, such as inference, analysis of variance, linear models, regression, survival analysis, non-parametric analysis, estimation, hypothesis testing, and statistical modeling
• Understanding of clinical trial concepts, such as randomization, hypothesis testing, estimation of treatment effects, sample size calculation, etc.
• Ability to do advanced statistical analyses, program tables and graphs, and perform data transformations.
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.
• Excellent problem-solving skills
• Excellent presentation skills

Competencies:

• Sound judgment/decision making
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Service oriented, accountable and flexible
• Competency in written and spoken English
• Follow applicable regulations, including FDA, ICH, and Precision Policies and Procedures
• At all times to promote the image of Precision, acting as an ambassador to the Company
• Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)