Position Summary:
Job Description
Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, 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 and/or verify randomization schedules
- Develop and review statistical methods of the clinical study protocol including complex study designs
- Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design
- Provide input into development of case report forms (CRFs)
- Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase
- Review statistical analysis plans written by other biostatisticians
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
- Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
- Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives
- Review output across programs to ensure consistency.
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded 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
- Lead all statistical activities for study within timelines
- Independently perform budget health review on projects and review monthly invoices
- Perform oversight responsibilities on projects for other biostatisticians
- Assist with budget development and present at bid defense meetings
- Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.)
- Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope
- Other duties as assigned
Qualifications:
Minimum Required:
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience
Other Required:
- Experience with SAS
- Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
Preferred:
- Experience with Oncology and rare diseases
- Broad experience with late phase and/or submissions
- Experience in consulting with clients on study design
- Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data)
Skills:
- Mastery of statistical principles underlying clinical trials
- Mastery of SAS programming skills and familiarity with other packages
- Outstanding statistical skills
- Excellent consultative skills
- 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 teach others to maintain effective working relationships with coworkers, managers and clients
- Service oriented, accountable and flexible
- Competency in written and spoken English
- Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures
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