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Associate Director, Biostatistics jobs in United States
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Tarsus Pharmaceuticals, Inc. · 23 hours ago

Associate Director, Biostatistics

Tarsus Pharmaceuticals, Inc. is looking for an Associate Director, Biostatistics to provide expert statistics support and oversee statistical work for clinical trials. The role involves developing statistical analysis plans, presenting data reviews, and ensuring quality completion of clinical data deliverables while interacting with regulatory agencies such as the FDA.
BiopharmaBiotechnologyLife Science

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

Qualification

Statistical Analysis PlansSAS programmingFDA Regulations knowledgeBiostatistics expertiseClinical trial experienceCustomer service orientationCollaboration skillsProblem-solving skillsSelf-motivationAttention to detail

Required

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

Preferred

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

Benefits

Health, dental and vision insurance benefits
Generous paid time off, including vacation, holidays, and personal days

Company

Tarsus Pharmaceuticals, Inc.

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Tarsus (NASDAQ:TARS) is a biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care.

Funding

Current Stage
Public Company
Total Funding
$710.6M
Key Investors
Pharmakon AdvisorsVivo Capital
2025-03-12Post Ipo Equity· $125M
2024-04-19Post Ipo Debt· $75M
2024-02-29Post Ipo Equity· $100M

Leadership Team

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Jeffrey Farrow
Chief Financial Officer and Chief Strategy Officer
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Bobak Azamian
Chairman
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Company data provided by crunchbase