StatisticianBiostatistician
StatisticianBiostatistician
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Job Description
Statistician/Biostatistician
remote
Overview:
In collaboration with Client and aligned with project timelines and objectives the Contractor Statistician/Biostatistician will provide comprehensive statistical support across pharmaceutical ophthalmology clinical trials and related activities. The contractor will play a pivotal role in ensuring statistical rigor throughout clinical trials contributing to the design authoring of statistical analysis plans (SAPs) development of tables listings and figures (TLFs) and interpretation of clinical data. This role requires close collaboration with crossfunctional teams and active involvement in both the conduct and analysis phases of trials. The ideal candidate will have an understanding of regulatory requirements and statistical methodologies ensuring the successful execution and reporting of clinical studies.
Key Responsibilities:
- Lead statistical design and analysis: Collaborate with crossfunctional teams to design and manage the biostatistical components of ophthalmology clinical trials. Establish statistical frameworks and author SAPs ensuring robust design analysis and reporting of clinical trial data that aligns with regulatory requirements.
- Implement advanced statistical models: Apply sophisticated statistical methodologies tailored to ophthalmology clinical trials ensuring they align with trial objectives regulatory standards and health authority guidelines.
- Analyze and interpret clinical trial data: Summarize complex clinical trial data into tabular and graphical formats focusing on efficacy and safety endpoints. Provide actionable insights to guide decisionmaking and regulatory submissions.
- Collaborate with crossfunctional teams: Work closely with statisticians data scientists and programmers to ensure timely accurate statistical outputs for regulatory submissions and scientific publications. Provide guidance to statistical programmers for the accurate implementation of analyses.
- Support regulatory submissions: Review and contribute to study protocols SAPs and clinical study reports. Engage with regulatory authorities addressing statistical queries and ensuring compliance with submission standards.
- Conduct exploratory data analysis: Use advanced statistical techniques to identify trends patterns and potential safety signals within ophthalmology clinical trial data.
- Serve as the primary statistical contact during trials: Provide ongoing statistical input throughout the clinical trial process including handling protocol deviations interim analyses and data monitoring. Collaborate with clinical teams to ensure the integrity of trial execution.
- Collaborate on trial design and data collection: Partner with clinical teams to establish trial design standards and optimize data collection processes ensuring smooth trial conduct and highquality data management.
Qualifications:
- Advanced degree in Statistics Biostatistics or related field.
- Minimum of 5 years of experience in clinical trials with a focus on the pharmaceutical or biotechnology industries preferably in ophthalmology.
- Proven experience in authoring SAPs generating TLFs and supporting regulatory submissions.
- Proficiency in statistical software including but not limited to SAS and R.
- Familiarity with the Estimand framework and methodologies for handling missing data in clinical trials is preferred.
- Demonstrated ability to collaborate with crossfunctional teams and lead statistical analysis efforts from design through trial conduct and regulatory submission.
- Strong communication skills with the ability to clearly present statistical concepts and analyses to both technical and nontechnical stakeholders.
Employment Type
Full Time
