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Role Description

The Associate Director, Biostatistics possesses a unique combination of expert statistics support and systems and compliance.

• Ownership of all scientific and operational statistical work for assigned clinical trials. Implements design and analysis methods.
• Responsible for presenting data reviews as needed in ET and upper management circles.
• Oversee programming and track the status with respect to performance metrics, deliverables, and timelines.
• Develops study Statistical Analysis Plans, including table, figure, and listing (TFL) shells.
• Develops study documents such as data review plan, Topline Results plan, and Data Dissemination Plan to facilitate the review, summary, and dissemination of key study data/results.
• Provide statistical expertise in support of interactions with regulatory agencies such as the FDA to include pre-submission meetings/questions, responses to regulatory agency questions, face-to-face meetings with regulators, etc.
• Accountable for overseeing performance of external vendors responsible for statistical work and deliverables to ensure quality completion of clinical data related deliverables.
• Participate in the development of policies, SOPs, work instructions, and clinical development process improvements relating to statistics.
• Validate software, in the role of system owner or tester, and test SAS Macros and other programs, maintaining the required validation and testing documentation.
• Provide support to implementation and maintenance of clinical data visualization tools, such as JReview.
• Manage multiple and varied tasks, prioritize workload with attention to detail.
• In addition to the above, employees are required to carry out any reasonable request to perform other duties as may be required within the scope of the job title.

Qualifications

• A professional statistician (including a Statistics MS / PhD), with design and analysis consultancy skills and knowledge across a broad range of applications.
• Minimum of Master’s Degree +10 years of experience, Or PhD +8 in the medical device, pharmaceutical, biotech or CRO industry is required.
• Experience with ophthalmology therapeutics and interface with FDA/regulatory agencies is highly desirable.
• Ability to work cross-therapeutic areas preferred.
• Proficiency in statistical programming including but not limited to SAS.
• Knowledge of FDA Regulations and ICH/GCP Guidelines.
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, integrity, and trust building behaviors in all dealings is essential and required.
• Ability to work collaboratively to project plan, problem-solve and deliver results.
• Must have excellent customer-service orientation, high degree of professionalism and ability to work with limited direction.
• Self-motivated, with initiative and the ability to take ownership of and follow through with assigned tasks.
• Ability to multi-task and shift priorities quickly while working under tight deadlines.

Benefits

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals.
• We provide a hybrid work environment. Remote work is an option.
• This position reports directly to our Director, Biostatistics.
• Some travel may be required – up to 20%.
• The expected base pay range for this position is $165,000 - $231,000 plus bonus, stock equity, and comprehensive benefits.
• Our benefits include health, dental and vision insurance benefits to ensure your well-being.
• We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.