Lead Statistician

DURATION: Long-term, with 3 months of probation period

LOCATION: Yerevan, Armenia

APPLICATION DEADLINE: Open until filled

JOB RESPONSIBILITIES:

– Offer comprehensive support throughout the entire lifecycle of statistical analysis and deliverables, including Dry Runs, Interim, and Final analysis activities. Specialize in oncology, medical device, and pharmacology studies, ensuring the highest quality of statistical analysis;

– Contribute to the development and delivery of TLFs (Tables, Listings, and Figures) and FADS (Analysis Datasets), enhancing the reporting process and ensuring the accurate presentation of key study results.

– Apply advanced statistical techniques, including regression analysis, mixed-effect modeling, non-linear modeling, survival analysis, and Bayesian statistics, to extract valuable insights from complex datasets.

– Provide support for post-submission publication efforts, including the development and quality control of Clinical Study Reports (CSRs), manuscripts, and other publications. Ensure the accurate and transparent reporting of study results.

– Conduct data profiling and statistical inference using traditional supervised machine learning algorithms. Leverage statistical expertise to uncover patterns and trends within the data.

– Translate theoretical statistical concepts into practical, computationally programmed codes, facilitating the application of advanced statistical modeling techniques in a coding context.

 QUALIFICATIONS:

– University degree in Statistics, Biostatistics, Data Science, Mathematics, Computer Sciences, Economics or a related field; PhD degree is preferred;

– At least five years of experience in a relevant field;

– Experience with advanced statistical analysis and modeling approaches;

– Knowledge of pharmaceutical development process, clinical research, clinical data management, and clinical information systems is preferred;

– Strong statistical programming skills (R and/or Python);

– Strong analytical skills;

– Experience with large administrative databases such as healthcare claims survey or personnel data is preferred;

– Experience with Git, R Markdown, knitR or LaTex is preferred;

– GCP certificate is preferred;

– Excellent knowledge of English language;

– Knowledge of FDA, GDPR and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions;

– Ability to manage and coordinate with a team of statisticians, programmers, and data scientists, delegating tasks and effectively communicating the ideas;

– Ability to explain complex statistical methods and results to non-technical stakeholders and collaborate with cross-functional teams;

– Demonstrate ability to work independently in project management and decision-making;

– Exceptional time management skills and the ability to effectively prioritize and manage multiple projects and tight deadlines;

– Proven experience in leading teams of statisticians, data analysts, or data scientists;

– Ensures accuracy in statistical modeling, data validation, and interpretation of results;

– Maintain comprehensive and organized documentation of data, statistical methodologies, and processes.

– Experience in streamlining data analysis processes to improve efficiency and quality of output.

APPLICATION PROCEDURES: 

Interested candidates should submit a CV to: hr@clinsoftcsd.com   Applications will be reviewed on rolling basis with shortlisted candidates invited for an interview via virtual or in person call.