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 USDKiniksa is an Equal…