Director, Biostatistics

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA-approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact-shaping the future of medicine while improving the lives of patients who need it most.

Reporting to the Biometrics Head, the candidate will be working in a cross-function team to provide the statistical expertise to multiple Research and Development programs. He/she will be responsible for leading, developing, and implementing statistical solutions to assure timely completions of Biometrics deliverables.

Responsibilities (including, but not limited to):

• Familiar with authority guidance documents such as ICH E8, E9, and E9 (R1)
• Provide leadership, guidance, and strategic input as the lead statistician on one or more projects
• Accountable for statistical aspects of clinical development plans, studies and submission activities
• Participate in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents including ICH/FDA E9 (R1)
• Oversee definition and implementation of study/project level database (including derived database), analysis and reporting standards. Coordinate with Data Management and Programming to target high quality databases and specifications at project level.
• Plan and direct study/project level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
• Conduct statistical analyses for clinical trials and provide expertise on SAS procedures
• Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
• Consider and evaluate alternative analysis methodology and data presentation techniques
• Collaborate with clinical research and development team to support publications, regulatory submissions, and other related activities including statistical innovation research

Qualifications & Experience:

• PhD in statistics/biostatistics with minimum of 8 year of experience in pharma/biotech
• Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data presentation and interpretation practices
• Strong statistical research ability for statistical methodology
• Experience with IND, NDAs, MAAs and other regulatory submissions a plus
• Ability to work effectively in a cross-functional environment
• Strong statistical programming skills using SAS, R and other relevant software
• Experience with clinical research preferred
• Good communication and interpersonal skills
• Strong project management and communication skills
• Excellent knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
• Excellent knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$235,000—$300,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.