Associate Director, Biostatistics

the Tarsanet Internal Career Center • Irvine, CA

1d • $165,000 - $231,000 • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience with ophthalmology therapeutics and interface with FDA/regulatory agencies is highly desirable.
• Ability to work cross-therapeutic areas preferred.

Responsibilities

• 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.

Benefits

• We provide a hybrid work environment. Remote work is an option.
• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director