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Clinical Trial Data Analyst

2 months ago

Rockville, United States Kolon TissueGene, Inc. Full time

About the Company: KOLON TISSUEGENE is a leader in biopharmaceuticals, specializing in cutting-edge regenerative medicine. With a global footprint and a commitment to innovation, we strive to transform patient care through advanced therapies. We are at a pivotal moment and are building the dream team to bring our vision and years of efforts to life.


Job purpose


The Clinical Data Analyst in the Bioinformatics team is pivotal for conducting and validating statistical analyses from vendors. This role requires strong statistical and programming skills to ensure accuracy and compliance with project goals and regulatory standards. Effective collaboration across teams and vendors is crucial, emphasizing communication and coordination. Beyond programming, the analyst interprets data strategically, applying deep statistical knowledge to manage multiple projects effectively.


Duties and responsibilities

  • Conducts and validates statistical analyses across phase I-IV clinical trials.
  • Ensures data accuracy and prepares analyses for publications.
  • Develops and maintains SOPs and ensures regulatory compliance.
  • Collaborates closely with teams and vendors to uphold quality standards.
  • Requires proficiency in statistical methodologies, SAS programming, and strong project management and communication skills.


Qualifications

  • Master’s degree in Statistics, Biostatistics, Data Science, or related field required.
  • Minimum 5 years of statistical analysis and programming experience, proficient in SAS applications.
  • Expertise in regression analysis, hypothesis testing, multivariate analysis, survival analysis, logistic regression analysis, and missing data analysis.
  • Understanding of clinical trial design, sampling estimations, and statistical inference.
  • Knowledgeable in developing, reviewing, and validating database specifications and analysis outputs.
  • Keeps updated on industry developments, contributing to methodological innovation.
  • Familiarity with regulatory guidelines such as ICH E3, E6, and E9 relevant to clinical trials.
  • Experience with industry data standards like CDISC, SDTM, CDASH, ADAM, and their application in statistical programming.
  • Strong interpersonal skills, proficient in oral and written communication, and skilled at collaborating with diverse teams and external vendors.
  • Proven ability to manage multiple projects, interpret statistics, strategize analyses, and align activities with project goals.


Working conditions


Up to approximately 15% travel is required.


Physical requirements

  • Position requires extensive keyboarding involving motion with figures.
  • Position requires extensive use of telephone and face-to-face interactions.
  • Ability to lift up to 25 lbs


Direct reports


None


Pay range and compensation package:

  • Competitive salary and discretionary performance-based bonuses.
  • Comprehensive health and wellness benefits package.
  • Opportunities for professional development and career growth in a dynamic industry.


Equal Opportunity Statement:

Kolon TissueGene is proud to be an equal opportunity employer, fostering a workplace that embraces and celebrates diversity. We believe in creating an inclusive environment where all employees feel valued and empowered. Qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. KTG welcomes individuals from all backgrounds and is committed to supporting visa sponsorship for qualified candidates as needed.


Join KOLON TISSUEGENE at this pivotal moment and contribute to pioneering advancements in regenerative medicine while shaping a diverse and inclusive workplace. We value your unique perspectives as we deliver our mission of improving patient outcomes globally.