Senior Biostatistician - Work From Home
Posted on Jan 18, 2019 by Sarah Cannon Clinical Operations
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Sarah Cannon,the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
**This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role.
Summary of Key Responsibilities:
Responsible for ensuring that appropriate statistical techniques are used which ensure the scientific validity and overall quality of clinical trial results. Perform statistical analysis, contribute statistical input when requested, and represent the Biostatistics function of Sarah Cannon to external partners.
Duties and Responsibilities
Duties include but are not limited to:
- Represent biostatistics department on project teams, provide support and guidance on data and statistical-related issues to the teams, attend project team meetings as necessary, and be responsible for the quality, accuracy and timely completion of the assigned tasks:
- Provide statistical input and support related to trial design and in the development of protocol synopses, protocols and CRFs
- Advise Data Management with respect to database design and documentation to ensure that all data required for analysis purposes are captured adequately
- Develop randomization schema
- Develop statistical analysis plans (SAP)
- Perform data review to ensure data are suitable for analysis
- Efficiently and effectively coordinate statistical activities for multiple projects simultaneously
- Assist in the developing, maintaining and producing statistical programs and specifications used in creating analysis datasets, tables, listings and figures
- Conducts quality control of project deliverables, ensure the output meets expectations
- Provide statistical insight in the interpretation and discussion of study results, and provide statistical contribution to the integrated clinical study reports and publications
- Maintain & archive program documentation - both electronic & paper - in an appropriate manner
- Keeps management / statistical lead abreast of issues and progress on all assigned projects
- Monitor project budgets and identify resource or scope of work changes
- Maintain professional statistical standards by keeping abreast of new developments in statistics, drug development and regulatory guidance through literature review and attendance/participation at workshops and professional meetings
- Understand and apply regulatory guidelines/developments and industry standards/best practices on statistics and SAS programming
- Contribute to the development and implementation of internal process improvement initiatives
- Collaborate with all functions to earn their respect as a trusted and value-driven business partner
- Work collaboratively with Sarah Cannon scientists and authoring physicians
- Work collaboratively with vendors and other external partners
- Represent Sarah Cannon to external partners in a professional manner
- Provide statistical advice within Sarah Cannon or by external partners
- Support business development activities by attending sponsor bid defense meetings
Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience
- Hands-on experience and knowledge with SAS and other statistical software
- Good knowledge in applied statistics including study design methodologies, categorical data analysis, survival analysis etc. Exposure to the use of modeling and simulation to enhance clinical trial design and decision making would be advantageous.
- Good understanding of clinical research and drug development process, and requirements on regulatory submissions and compliance
- Familiar with ICH guidelines, regulatory requirements and industry standards (eg CDISC) and awareness of best practices related to statistical and programming activities
- Good teamwork skills placing emphasis on supporting the goals of the group
- Excellent time/project management and problem solving skills
- Excellent verbal and written communication skills including presentation skills
- Ability to work with within deadlines and according to procedures and rules
- Ability to manage multiple protocols and participate in multiple clinical project teams simultaneously
- Excellent attention to detail
- Absolute integrity, honesty, reliability and passion / enthusiasm about advancing therapies for patients
- Patient / Customer-focused
- Trustworthy and respectful
- Credible and influential
- Optimistic and positive
- Passion for results
- Attention to details
- Effective communication skills
- Project management skills
Minimum Required: Master's Degree (1-2 year program)
Preferred: Doctorate Degree
- At least 5 years of biostatistics in a regulated clinical research environment (pharmaceutical / biotechnology / CRO) required
- Ability to program in SAS
- Experience leading statistical activities in clinical research
- Knowledge of basic statistical design, analysis, ICH guidelines and programming techniques utilized in clinical research.
- Experience with regulatory submissions and support
- Knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, and non-parametric methods.
- Oncology experience
**If interested in advancing your career with a growing leader in clinical research please apply today!
At its founding in 1968, Nashville-based HCA was one of the nation's first hospital companies. Today, we are the nation's leading provider of healthcare services, a company comprised of locally managed facilities that includes about 165 hospitals and 115 freestanding surgery centers in 20 states and England and employing approximately 204,000 people. Approximately four to five percent of all inpatient care delivered in the country today is provided by HCA facilities. Milton Johnson serves as Chairman and Chief Executive Officer of HCA.