Precision for Medicine are recruiting an experienced Senior Biostatistician/Principal Biostatistician to work remotely in Poland, Hungary, Serbia, Romania or Slovakia.
Position Summary:
To 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.
For this level, the role will include project work as a Lead Biostatistician, and additionally mentoring and supporting more junior team members.
Essential functions of the job include but are not limited to:
- Generate randomization schedules
- Assist with statistical methods review of the clinical study protocol.
- 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
- Validate 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 statistical support for supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Assist with statistical consulting tasks
- Review output across programs to ensure consistency
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician
- 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
- Additional responsibilities for Senior and Principal levels, as senior team members
Qualifications:
Minimum Required:
- Master's degree / PhD or equivalent in Statistics, Biostatistics, or related field with strong relevant experience
- At least 7 to 10 years experience working as a Biostatistician for a Clinical Research Organisation
Other Required:
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, 21 CFR Part 11, and FDA guidelines
- Experience with SAS
- Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
Preferred:
- Experience with Oncology desirable
- Knowledge and experience of CDISC data structures
Skills:
- Understanding of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
- Understanding of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data
- 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
- Fluent 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.)
#LI-NC1 #LI-Remote
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Last updated on Aug 20, 2024