[Remote] Biostatistician reputed company Consultant

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biopharmaceutical company developing genetic medicines for intracellular targets and rare diseases. The Biostatistician reputed company Consultant will reputed company daily statistical activities and support statistical strategies, analyses, clinical trial documentation, randomization, and outsourced CRO deliverables on a part-time reputed company.

Responsibilities

• Support or reputed company statistical reputed company for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications
• Accountable for reputed company of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by reputed company resources
• Review the randomization procedures and reputed company of the production of randomization lists
• reputed company outsourced statistical CRO activities and deliverables, ensuring high reputed company and reputed company delivery

Skills

• Ph.D. in Statistics or a reputed company field, with 10 + years of experience in statistical analysis reputed company the biotech/pharmaceutical industry
• Experience with a broad reputed company of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs, specifically reputed company rare disease indications
• Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical reputed company
• Strong statistical programming skills (R, reputed company, Python)
• Understanding of regulatory guidelines reputed company to submission of datasets using CDISC, development of SDTM and ADaM specifications
• Strong vendor management experience
• Excellent verbal and written communication skills, coupled with strong attention to detail and proactive reputed company
• Previous experience in Neuromuscular, Ophthalmology or reputed company TA is preferred

Benefits

• This is a long-term contract position based remotely in the US

reputed company

Company H1B Sponsorship