Lead statistical design and analysis

Job title: Lead statistical design and analysis

Company: Intellectt


Job description: Role: Lead statistical design and analysis
Location: RemoteType: Long TermKey Skills: Statistics, Biostatistics, Clinical TrialsQualifications:

• 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 cross-functional 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 non-technical stakeholders.

Key Responsibilities:

• Lead statistical design and analysis: Collaborate with cross-functional teams to design and manage the bio-statistical 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 decision-making and regulatory submissions.
• Collaborate with cross-functional 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 high-quality data management.

Expected salary:

Location: USA

Job date: Tue, 29 Oct 2024 23:31:52 GMT

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