דרושים » מדעים מדוייקים » Principal Biostatistician

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חברה חסויה
Location: Haifa
Job Type: Full Time
We are looking for a principal biostatistician for our global biostatistics and data management team.

As a principal biostatistician, you will lead the statistical aspects of our clinical trials. The role will involve defining and implementing statistical techniques commonly used for oncology clinical trials, working on key department deliverables involving designing and analyzing clinical trials, and leading the statistical aspects for regulatory submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Modeling clinical data with Cox Models, Kaplan-Meier Estimates, competing risks.
Contribute to study design by incorporating adaptive design, superiority and non-inferiority trials, propensity score matching, and conducting meta-analyses.
Contribute to protocol development in conjunction with clinical development and operations teams and responsible for assessing the feasibility of the study endpoints and developing the Statistical Analysis Plan (SAP).
Report the study results in the Clinical Study Report (CSR).
Oversight of the CRO and validate other vendors' statistical activities.
Provide statistical advice and manage statistical aspects of clinical and preclinical projects.
Approve statistical outputs: Table, Listing, and Figures (TLFs) and the analysis datasets produced by the statistical programming team using SAS.
Work within a multidisciplinary team and serve as a point of contact between clinical operation, CRO, and SAS programmers within the statistical department.
Provide statistical input for the study-related documents: study execution plans (including Data Management Plan), eCRF design and Edit Checks specifications, eCRF completion guidelines and data reconciliation plans.
Review SAS coding and specifications.
Other responsibilities as assigned.
Requirements:
Qualifications:
Ph.D./M.Sc. degree in Statistics or Biostatistics.

Knowledge:
At least 5 years of experience leading statistical aspects in late-phase clinical trials, and oncology studies would be an advantage.
Excellent knowledge of common statistical techniques used in oncology clinical trials, with experience writing SAP and the statistical sections of the CSR.
Previous experience with FDA and/or EMEA submissions.
Excellent proficiency in programming with SAS and/or R.
Knowledge of ICH-GCP, CFR, CDISC, and other relevant regulations and guidelines.
Fluent in English (verbal and written) and excellent communication skills.

OTHERS:
Ability to work both independently and collaboratively
Responsibility, detail-oriented, and creative with excellent organizational skills
strong critical thinking and problem-solving skills
This position is open to all candidates.
 
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משרות דומות שיכולות לעניין אותך
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חברה חסויה
Location: Haifa
Job Type: Full Time
We are looking fora an experienced Senior Data Engineer to join the Real World Evidence team.

The Senior Data Engineer will be responsible for building and maintaining the Real-World Evidence data lake and implementing data migration processes with proper structuring and integration. Tasks include parsing EMR resources, developing or configuring tools for efficient data annotation, writing scripts to detect discrepancies, and monitoring data coverage and quality metrics. Additionally, building dashboards to aggregate key data points, assist data annotators in prioritizing and simplifying their work, manage access control security policies, and perform data analytics tasks.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Design, develop, and maintain scalable data pipelines and ETL processes.
Collaborate with clinicians, data quality experts, and other stakeholders to understand data requirements and deliver solutions.
Ensure data quality, integrity, and security across all data platforms.
Optimize and improve existing data systems for performance and scalability.
Implement data governance and best practices for data management.
Monitor and troubleshoot data pipeline issues to ensure smooth operations.
Program data validations and quality checks to ensure data integrity.
Define, implement, and review data quality metrics; perform trend analyses; identify and support the resolution of data issues.
Support the interrogation, analytics, and reporting of clinical real-world data.
Support research-specific quality audits and regulatory authority inspections, acting as a subject matter expert.
Requirements:
Qualifications:
Bachelors degree or higher, preferably in an engineering-related field (Computer Science/Statistics/Engineering).

Knowledge:
At least 3 years of proven experience as a Data Engineer or in a similar role.
Proficiency in SQL and experience with relational databases.
Familiarity with cloud platforms such as AWS, Azure, or Google Cloud.
Strong programming skills in languages like Python, Java, or Scala.
Knowledge or experience in handling clinical data.
Excellent verbal and written communication skills, capable of providing clear, concise, timely, and relevant information.
Strong ability to identify and resolve complex challenges using critical thinking skills.
Exceptional organizational and record-keeping skills with keen attention to detail, precision, and accuracy.
Ability to manage and prioritize multiple tasks simultaneously, proactively solve problems, and handle competing priorities and deadlines.
Demonstrated ability to work effectively in a diverse team, including analysts, clinicians, and engineers.
Familiarity with EMR data and FHIR resources advantage.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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עדכון קורות החיים לפני שליחה
8123382
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