KIYATEC Inc. is a privately held life science company located in Greenville, SC, leveraging its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs, targeting a spectrum of solid tumors. The platforms are positioned to address the gap-defining limitations of current cancer drug selection and create game changing information for patient specific cancer drug selection prior to treatment. The company has an active research and development project portfolio developing, validating, and performing standard and custom cell-based assays for biopharma clients. Additionally, KIYATEC operates a CLIA certified laboratory, and currently performs oncology patient drug response profiling as part of a commercially available assay and under IRB approved clinical research studies. The company’s Biostatistician works in partnership with both R&D and Clinical Affairs to analyze large datasets and unlock hidden statistical and data-driven information.

Position Summary

KIYATEC is seeking a Biostatistician for immediate hire; preferred location is Greenville, SC headquarters – will also consider well-qualified remote candidates. This individual will play a key role in analyzing data for KIYATEC’s 3D ex vivo assay results related to clinical studies/trials and research projects as well as initiating the expansion of a comprehensive Data Analysis/Biostatistics division within KIYATEC. The Biostatistician will lead comprehensive analytical and biostatistical efforts, including the development of computational methods to evaluate datasets and variables and their correlation to therapeutic drug response. The Biostatistician will identify scientifically and clinically relevant findings, conducting systematic analyses of internal data and mining external datasets (including public databases) to leverage KIYATEC data supporting business and clinical needs. The Biostatistician will help develop evidence to support clinical decision making and methods and tools for R&D development and validation studies.

Position Responsibilities – Essential

• Lead and plan data analyses and data management related to clinical studies and research projects.
• Analyze data and Identify trends that computational approaches can address. Develop analysis solutions both independently and collaboratively.
• Proactively discusses findings and analytical issues related to clinical and research projects.
• Provide biostatistical expertise in the design of single and multi-institutional clinical studies/trials and research projects, including thought processes of endpoint selection and statistical considerations for predictive model parameters and validation.
• Evaluate biostatistical model performance.
• Contribute meaningfully and creatively to data analysis discussions and proactively identify next steps for analyses.
• Prepare analyzed data and interpretation of results for corporate discussion, ensuring that results and conclusions are presented accurately and without bias.

Position Responsibilities – Internal Engagement

• Lead development of computational methods and tools to analyze the potential for data-driven patient stratification and clinical decision making.
• Perform as corporate subject matter expert for biostatistical data analysis
• Draft statistical sections for peer-reviewed journal methods, study protocols, study synopses.
• Actively participate in the preparation of written analyses and result summaries for study reports, scientific meeting presentations, white papers, and peer-reviewed journal manuscripts.
• Help direct the expansion of a Data Analysis/Biostatistics division of KIYATEC
• Serve as point for data discussions occurring internally and may represent KIYATEC as data contact between company and collaborators

Position Responsibilities – Other/General

• Support company goals and objectives, policies and procedures, performance management programs, and applicable national and local regulations.
• Maintain current knowledge in oncology and relevant clinical trials through review and analysis of published literature.
• Understand and proactively keep up with guidelines from the FDA, ICH, EMEA, IRB, HIPAA, or other regulatory agency as they apply to handling of clinical data, programming, and statistics. Monitor compliance to required standards of own work.
• Use appropriate and ethical judgment to ensure unbiased analysis and interpretation of all data
• Perform other duties as assigned.

Essential Skills and Experience – Required

• PhD in the biological sciences with strong background in biostatistics and computational methods, including inference approaches and iterative model development
• High proficiency and practical software development skills in standard scripting language (e.g., R, SAS, Python)
• Strong expertise analyzing complex data sets. Ability to independently carry out analyses of large data sets
• Experience with oncology datasets very strongly preferred
• Familiarity with molecular profiling and cancer biomarkers
• Experience collaborating with clinical and research investigators
• Experience in study design and data analysis for a wide range of experimental, observational, interventional, clinical and longitudinal studies, experience with analysis of large medical databases
• Strong experience with sample size calculations and methodologies
• Experience performing internal and external validation analysis and modeling
• Experience with oncology/immuno-oncology/clinical data
• Experience writing/publishing biostatistical data
• Highly proficient with MS Office and GraphPad Prism software
• Excellent problem-solving and organizational skills
• Excellent interpersonal skills with internal and external clients/collaborators. Ability to operate both as a team and independently, with adaptability to changes while maintaining team focus
• Strong written/verbal communication and data presentation skills.
• Detail-oriented, hands-on, willing to perform simple and complex tasks required for successful execution of duties; honest and reliable
• Immediate availability for full-time employment
• Must be legally authorized to work in the US without sponsorship
• Based in Greenville, SC preferred

Essential Skills and Experience – Beneficial

• Experience working with clinical data management systems (multiple preferred) and in-depth knowledge of at least one electronic data capture system (EDC)
• Demonstrated knowledge of GCP and all applicable US regulations governing clinical research
• 2+ years relevant clinical research experience in biotechnology/pharmaceutical industry

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