Drive impactful statistical methodologies in clinical trials for a leading pharmaceutical organization. Collaborate with cross-functional teams to ensure data integrity and regulatory compliance. Enhance study efficiency through innovative analysis techniques.
Senior Manager, Biostatistics (R)
in Healthcare + Life Sciences ContractJob Detail
Job Description
Overview
- Lead statistical study design and analysis for clinical trials in a dynamic pharmaceutical environment.
- Provide technical biostatistical input to ensure integrity and accuracy of study results.
- Collaborate with cross-functional teams to meet deliverables and timelines effectively.
- Contribute to innovative statistical methodologies and regulatory document preparation.
- Act as a statistical study lead, guiding strategic discussions and project execution.
- Develop and review statistical analysis plans, CRFs, and study documentation.
- Ensure compliance with regulatory guidelines and statistical standards.
- Support data analysis and reporting to enhance study efficiency and sensitivity.
Key Responsibilities & Duties
- Lead study-level statistical tasks, ensuring methodological integrity and strategic alignment.
- Design statistical sections of protocols, SAPs, and DMC charters for clinical trials.
- Develop and review TFL specifications, CRFs, and study randomization files.
- Collaborate with biometrics and cross-functional teams to meet project timelines.
- Conduct statistical analyses and propose novel methodological approaches.
- Contribute to regulatory documents and scientific publications with statistical insights.
- Participate actively in study-related meetings and strategy discussions.
- Ensure adherence to ICH guidelines and regulatory authority standards.
Job Requirements
- Master's or PhD in Statistics or Biostatistics with relevant clinical trial experience.
- Minimum 3 years (PhD) or 6 years (Master's) of post-graduate experience.
- Proficiency in SAS and R, with knowledge of CDISC standards preferred.
- Experience in NDA/BLA/MAA activities and regulatory interactions.
- Ability to lead statistical studies and contribute to cross-functional discussions.
- Solid understanding of mathematical and statistical principles.
- Familiarity with ICH guidelines and FDA/EMA regulatory standards.
- Strong organizational, problem-solving, and prioritization skills.
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