Director Biostatistics - REMOTE

Proclinical is seeking a remote Director Biostatistics with a leading therapy organization. As the Director Biostatistics, you will provide statistical leadership in one or more indications, including support of clinical development planning and execution for multiple clinical trials. In addition, you will perform statistical analysis and develops tracking systems to determine the efficiency of clinical trials.

Job Responsibility:

• Provide statistical support to clinical development plan for multiple clinical trials
• At study level, provide statistical input to study protocols, develop statistical analysis plan, and tables/listings/figures
• Assist in writing relevant sections of the clinical study report and publications
• Monitor and guide internal and CRO project activities including timelines, deliverables, and resources
• Participate in pre-IND and NDA/BLA activities
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
• Develop and implement department standards and lead process improvements
• Other duties as assigned

Skills and Requirements:

• PhD or MS in Biostatistics or Statistics required
• At least seven (7) years' experience for PhD, or nine (9) years' experience for MS as statistician in the pharmaceutical or biotechnology industry.
• Oncology (especially solid tumor) clinical trial experience preferred; knowledge of immuno-oncology is a plus.
• Experience with advanced study design and up to date biostatistical methodologies.
• Experience of NDA/BLA eCTDs or other global regulatory submissions. Experience of direct interaction with health authorities.
• Experience as an independent lead statistician with responsibility for multiple studies or projects.
• Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively.
• Good knowledge of statistical programming languages (including SAS).
• Knowledge of SDTM/ ADaM.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or m.hermiz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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