About the Role

The jobholder will be responsible for all aspects of statistical project support to clinical studies. The jobholder will independently and proactively ensure project statistical support needs are fully met and study designs and analyses are statistically valid and meet the recognized international standards.

The job holder is a senior statistician, with design and analysis consultancy skills in both clinical and research applications. The jobholder will expertly and independently: provide consultancy advice on study design, write protocol statistical considerations sections and statistical analysis plans, and conduct analyses, report, and disseminate study results.

Let’s talk about some of the key responsibilities of the role:

Expert statistics support

• Lead project statistical support ensuring that needs are fully met by expert and timely statistical consultancy and support.
• Responsible for all scientific and operational statistical work for assigned clinical trials. Implements design and analysis methods.
• Oversee database status with respect to performance metrics, deliverables, and timelines. Define, forecast, and manage statistical and data management (DM) resources (personnel, technology, vendors).
• Develops statistical section of protocols, including sample size estimates and randomization plans.
• Authors 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.
• Provides input into the programming specifications and review. Collaborates with statistical programming and other vendors to ensure timely delivery of TFLs with high quality.
• Contributes to clinical study reports and related processes.
• Develop, test, and run statistical programs for analysis datasets, report tables, graphics, and statistical analysis, liaising with statistical programmers as appropriate.
• 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.
• Oversee/consult statistical work at CROs if applicable.
• Accountable for overseeing performance of external vendors responsible for data management deliverables to ensure quality completion of clinical data related deliverables.
• Provide DM operational leadership for the direction, planning, execution, collection, and handling of all clinical data to the highest quality standard while ensuring compliance with industry established standards and reporting requirements.
• Participate in the development of policies, SOPs, work instructions, DM standards and clinical development process improvements relating to clinical data management.

Systems, Compliance and Self Development

• Identify and lead systems and process development to improve the efficiency and quality of work within the statistics function.
• Validate software, in the role of system owner or tester, and test SAS Macros and other programs, maintaining the required validation and testing documentation.
• To perform all activities in compliance with relevant GCP, and Quality Systems standards.
• Work collaboratively with cross functions and participant in meetings as applicable
• 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.

Factors for Success:

• A professional statistician (including a Statistics MS / PhD), with design and analysis consultancy skills and knowledge across a broad range of applications.
• At least 7 years of experience in the medical device or pharmaceutical 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, ICH/GCP R2, and Good Clinical Data Management Practices (GCDMP).
• 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.
• 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

A Few Other Details Worth Mentioning:

• 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. Relocation is provided and remote is an option for people who cannot move to Southern CA.
• This position reports directly to our Vice President, Clinical Development
• Some travel may be required – up to 20%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $158,200 - $221,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. 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. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/tarsus2024BenSnapshot.

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