Director, Advanced Analytics/Biostatistics

An ideal candidate must have at least six or more years of experience in a lead biostatistician role with familiarity with primary observational data studies. Working knowledge of CDISC standards and R will be a plus. Other considerations include:

• Experience working in a CRO or pharmaceutical organization
• Experience in developing both internal and external consultative relationships with senior management and executives
• Willingness to work under pressure to meet multiple and sometimes competing deadlines
• Excellent scientific, business writing, and communication presentation skills with close attention to detail
• Exceptional communication skills, especially in the relaying of technical information and project concepts

Position Overview

The Director Biostatistics is responsible for ensuring that all assigned projects are being conducted in an efficient manner and that quality and client satisfaction is maximized at all times -- ensuring the direction of the project and the quality of the deliverables meet the project objectives and the client needs. Further, Directors are expected to support and train the Senior associates and Associates in their daily duties and to flag any areas of acute training needs to their line managers. Supported by the senior staff and Business Development partners, the Director is responsible for maintaining client relationships on their projects as well. In addition, the individual will be expected to contribute to the continuing growth and improvement of the business unit through taking ownership of company and business unit processes and initiatives as well as contribution to the Senior Management Team's focus and direction.

The Director Biostatistics will also work independently in reviewing protocols, developing SAPs (including mock shells), developing data specifications per CDISC standards, programming and quality control of derived datasets and statistical outputs (e.g., tables, listings and figures),  production of reports, and providing statistical advice to study teams and clients.

Objectives of the role will include:

• Acting as Lead Biostatistician to interact with the study team and the sponsor
• Drafting statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedules per study design and relevant specifications
• Reviewing case report forms (CRFs), data management plans, data specifications, and other related study documents
• Independently developing statistical analysis plans
• Preparing specifications for CDISC and other analysis datasets
• Independently developing SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan
• Performing QC of TLFs, CDISC and other analysis datasets
• Reviewing study protocols and providing input to statistics section
• Providing statistical input to Clinical Trial Reports
• Aiding business development with statistical considerations for new study bids, preparing biostatistics budgets, and attending bid defense meetings
• Serving as a mentor to junior-level biostatisticians to help develop skills

Qualifications

• Expertise in primary observational studies
• Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specifications 
• Familiarity with specifications for CDISC and other analysis datasets
• Strong statistical programming skills with standard software, including SAS and R
• Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly
• Ability to communicate effectively, in non-technical terms, with project team members
• Ability to work well in a team as well as independently and take leadership roles with regard to methodological elements in projects

Education and Experience

MSc or PhD in Biostatistics, Statistics, or a related field with 6 or more years of relevant experience

Language Skills

Competent in written and spoken English

Computer Skills

SAS (Base, Stat, Graph, Macro) and R