Director, Biostatistics

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Job description

Position Summary:

The Director of Biostatistics, will serve as the project lead statistician responsible for statistical activities at study level and project level, including protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at Omeros. This role will also oversee CRO statistics deliverables for all Omeros studies.

Who is Omeros?

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, as well as cancers and addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 multi-ascending-dose clinical trial. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder and, in addition, is being developed as a therapeutic for other addictions as well as for a major complication of treatment for movement disorders. Omeros also is advancing a broad portfolio of novel immuno-oncology programs comprised of two cellular and three molecular platforms. For more information about Omeros and its programs, visit .

Good things are happening at Omeros!

Come join our Omeros Clinical team!

Essential Duties & Responsibilities:

• Develop, lead, and serve as the primary point of contact for the statistical program strategy for early and/or late-stage drug development projects
• Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis and reporting of clinical trial data
• Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
• Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes
• Review and provide appropriate input to the design of Case Report Forms and database design
• Monitor the conduct of the clinical trials, review data, and perform quality control with respect to data to be analyzed and the programs to be used for the analysis
• Participate in Clinical Project and Study Team meetings
• Responsible within the Clinical Team for the quality, accuracy, and timely completion of assigned statistical and programming tasks

Team Leadership:

• Supervise a capable, self-motivated team of statisticians
• Set priorities in alignment with the clinical team and assign resources for the management of requests regarding statistical analysis/report

Education, Experience, Skills, and Knowledge:

• PhD in Biostatistics
• Minimum of 8-12 years of drug development experience
• Proficient independent biostatistical consulting expertise
• Proficient in either SAS or R statistical programming
• Excellent analytical thinking skills
• Excellent written and verbal communication skills

Other Requirements:

• The employee is occasionally required to travel overnight with the ability to travel 20% of the time

Physical Demands:

• May encounter prolonged periods of sitting
• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.

Compensation and Benefits

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Director, Biostatistics is $204,000 - $255,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit .

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to or contact Omeros, asking for Human Resources, at .

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