HCA, Hospital Corporation of America Principal Biostatistician, Work From Home in Nashville, Tennessee

Summary of Key Responsibilities:

Responsible for ensuring that appropriate statistical techniques

are used which guarantee the scientific validity and overall quality of clinical trial results. Perform

statistical analysis, contribute statistical input when requested, and represent the Biostatistics function of

SCRI to external partners.

Duties and Responsibilities:

Duties include but are not limited to:

• Act as a lead representative of the 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


o Provide statistical input and support related to trial design and in the development of

protocol synopses, protocols and CRFs

o Advise Data Management with respect to database design, validation checks & key data,

to ensure that all data required for analysis purposes are captured adequately

o Coordinate the development of randomization schema

o Coordinate & develop statistical analysis plans (SAP)

o Coordinate & perform data review to ensure data are suitable for analysis

o Work with the programmers to provide definitions, specifications, documentations and

review of derived datasets required to produce the planned statistical outputs, including

tables, figures and listings

o Coordinate the production of statistical outputs for various analysis and reporting

purposes, and provide statistical review and program validation for each project, to

ensure the integrity, adequacy and accuracy of the outputs

o Provide statistical insight in the interpretation and discussion of study results, and provide

statistical contribution to the integrated clinical study reports and publications

o Maintain & archive program documentation - both electronic & paper - in an appropriate


o Keep management abreast of issues and progress on all assigned projects

• 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

• Lead or contribute to the development and implementation of internal process improvement


• Mentor more junior members of the Biostatistics team on project-related and statistical-related


• Collaborate with all functions to earn their respect as a trusted and value-driven business partner

• Work collaboratively with SCRI scientists and authoring physicians

• Work collaboratively with vendors and other external partners

• Represent SCRI to external partners in a professional manner

• Provide statistical advice and consultancy within SCRI or by external partners

• All other duties as assigned


• Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”

• During your employment with SCRI you will be routinely assigned training requirements. You

are expected to complete any training assignments by the due date.



• Strong hands-on experience and knowledge with SAS and other statistical software

• Strong knowledge in statistics including study design methodologies, categorical data analysis,

survival analysis, etc. Experience in the use of modelling and simulation to enhance clinical trial

design and decision making would be advantageous.

• Excellent 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


• Excellent 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


• Excellent attention to detail

• Excellent verbal and written communication skills and presentation skills

• Patient / Customer-focused

• Values-based

• Trustworthy and respectful

• Credible and influential

• Optimistic and positive

• Passion for results

• Attention to details

• Effective communication and leadership skills with junior level biostatisticians

• Project management skills





Minimum Required:

Master’s Degree


Doctorate Degree


Minimum Required:

Type of Experience-

• At least 6 years of biostatistics in a regulated clinical research environment (pharmaceutical /

biotechnology / CRO) required.

Preferred: Bayesian adaptive design experience for Phase I/II oncology

7 yrs.experience in the following:

• Experience in oncology highly desirable

• International experience and cross-cultural awareness preferable

• Experience in interactions/meetings and/or submissions with regulatory authorities (eg FDA,

EMA) would be advantageous

Appropriate education may be substituted for partial experience.

Title: Principal Biostatistician, Work From Home

Location: Tennessee-Nashville-Sarah Cannon Research Institute Clinical Operations

Requisition ID: 25319-3320