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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.
• Accountable for overseeing performance of external vendors responsible for statistical work and 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.
• 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.
• 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.
• Minimum of Master’s Degree +10 years of experience, Or PhD +8 in the medical device, pharmaceutical, biotech or CRO industry.
• 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.
• Ability to work collaboratively to project plan, problem-solve and deliver results.
• Excellent customer-service orientation and high degree of professionalism.
• 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

• Hybrid work environment with remote work options.
• Base pay range of $165,000 - $231,000 plus bonus, stock equity, and comprehensive benefits.
• Health, dental, and vision insurance benefits.
• Generous paid time off, including vacation, holidays, and personal days.

Company Description

Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.