Job description

Our client is a Biotech company located in San Diego, CA that is recognized as one of the top places to work in Southern California. Some occasional travel to site may be needed.

Job Summary:

Reporting to the Chief Medical Officer, the Director, Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.

Essential Duties and responsibilities:

• Independently leads the development and execution of statistical aspects for multiple complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
• Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations.
• Provides scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions.
• Develops statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays.
• Provides leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design.
• Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for that data will be included in SDTM.
• Collaborate with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting
• Manage biostatistics vendors, identify potential risks and resolve issues with CROs
• Takes accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.

Experience and education requirements:

• PhD in statistics or equivalent, with at least 10 years of relevant experience in biotechnology or pharmaceutical industry
• Demonstrated experience in providing statistical input and direction into the design of clinical studies
• Proficiency with statistical programming in SAS and/or R.
• Knowledgeable in CDISC standards, including SDTM, ADaM.
• Extensive knowledge of GCP, ICH guidelines, FDA regulations
• Preferably NDA experience, including eCTD submission.

Job Type: Full-time

Pay: $180,000.00 - $210,000.00 per year

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: Remote

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