Associate Director, Biostatistics Consultant

Parexel•Southport, NC

10d•Remote

About The Position

The Principal Biostatistician works independently across clinical trial projects of all complexity levels, including those with major regulatory impact. This position is highly visible within the organization and to external partners and is recognized as a statistical expert. The ideal candidate is a strong communicator, trusted advisor, and technical leader capable of driving statistical strategy and execution across multiple therapeutic areas. This position is focusing on Patient-Report Outcomes (PRO)

Requirements

Strong analytical skills
Strong project management skills
Professional attitude with excellent attention to detail
Thorough understanding of statistical issues in clinical trials
Ability to clearly describe advanced statistical techniques and interpret results
Familiarity with regulatory and research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
Prior experience with SAS programming required
Ability to work independently
Strong mentoring and leadership skills
Strong business awareness and business development aptitude
PhD or MS in Statistics or related discipline with substantial experience
Competent in written and oral English, in addition to local language

Nice To Haves

Knowledge of pharmacokinetic data is an advantage

Responsibilities

Provide broad statistical support, including trial design, protocol development, and CRF development for assigned studies
Lead production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports, and other supporting documentation
Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols
Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and statistical analysis plans
Serve in a supporting role as a non‑voting independent statistician, preparing data and analyses for DMC review
Support Business Development activities by contributing to study design discussions during internal and client meetings
Provide and explain sample‑size scenarios
Support proposal and budget development
Attend and prepare for bid defense meetings
Understand regulatory requirements across therapeutic areas and their implications for statistical methods, processing, and analysis
Understand, apply, and provide training in extremely advanced and emerging statistical methods
Contribute to the development and delivery of internal and external statistical training seminars and courses
Review position papers in accordance with current good statistical practice
Interact with clients and regulatory authorities
Review publications and clinical study reports
Travel to and actively contribute in client meetings (e.g., discussing analysis concepts or presenting study results)
Perform additional responsibilities as defined by supervisor or manager