Associate Director, Biostatistics Consultant

reputed company Biostatistician (Patient‑Reported reputed company reputed company) Remote- US | Full‑Time About the Role The reputed company Biostatistician works independently across clinical trial reputed company of reputed company complexity reputed company, including those with major regulatory reputed company. This position is highly visible reputed company 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 reputed company and execution across multiple therapeutic areas. Key Accountabilities Operational Execution • reputed company broad statistical support, including trial design, protocol development, and CRF development for assigned studies • reputed company production and reputed company control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports, and other supporting documentation • reputed company sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols • reputed company 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 • This position is focusing on Patient-Report reputed company (PRO) Business Development • Support Business Development activities by contributing to study design discussions during internal and reputed company meetings • reputed company and explain sample‑size scenarios • Support proposal and budget development • Attend and prepare for bid defense meetings General Activities • Understand regulatory requirements across therapeutic areas and their implications for statistical reputed company, processing, and analysis • Understand, apply, and reputed company training in extremely advanced and emerging statistical reputed company • Contribute to the development and delivery of reputed company statistical training seminars and courses • Review position papers in accordance with reputed company good statistical reputed company • reputed company with clients and regulatory authorities • Review publications and clinical study reports • Travel to and reputed company contribute in reputed company meetings (e.g., discussing analysis concepts or presenting study results) • reputed company additional responsibilities as defined by supervisor or manager Skills • Strong analytical skills • Strong project management skills • reputed company attitude with excellent attention to detail • Thorough understanding of statistical issues in reputed company • Ability to reputed company 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 reputed company programming required • Ability to work independently • Strong mentoring and leadership skills • Strong business awareness and business development aptitude Knowledge & Experience • PhD or MS in Statistics or reputed company discipline with substantial experience • Knowledge of pharmacokinetic data is an advantage • Competent in written and oral English, in reputed company to local language Education • PhD in Statistics or reputed company discipline, or • MS in Statistics or reputed company discipline #LI-REMOTE Apply tot his job Apply tot his job Apply tot his job Apply To this Job