Job Description
Job Summary: The
Senior Manager Statistics will be responsible for statistical activities across all stages of clinical trials, from protocol development through final study reporting. This role also supports statistical work related to drug in-licensing, regulatory filings, and post-marketing activities. The ideal candidate will bring strong statistical acumen, leadership, and a deep understanding of clinical research standards and regulatory guidelines.
Key Responsibilities: - Review clinical trial protocols and contribute to the design of study elements, including sample size calculations , statistical methodology, and timelines.
- Author and/or review statistical sections of protocols, SAPs, TFL shells, and variable derivation specifications.
- Review CRFs , database design , and edit check specifications to ensure data integrity and consistency.
- Monitor study conduct , quality surveillance plans , and data quality throughout the trial.
- Provide statistical and validation support for data analyses, including analysis datasets and TFLs .
- Review and contribute to clinical study reports (CSRs) , manuscripts , and other statistical documentation.
- Participate in the preparation of responses to health authorities and perform ad-hoc analyses as required.
- Provide statistical input to regulatory documents and filings.
- Collaborate effectively with cross-functional teams, CRO statisticians, statistical programmers, and vendors.
- Track and manage timelines related to statistical deliverables, proactively mitigating risks.
- Lead CRO statistical teams, review their deliverables, and ensure compliance with quality standards.
Required Qualifications: - Ph.D. in Statistics or Biostatistics with 4+ years of experience, or MS with 6+ years in the pharmaceutical or CRO industry.
- Proficiency in SAS programming and statistical software.
- Strong knowledge of industry standards including ICH guidelines , CDISC data structures , and FDA statistical requirements .
- Proven experience in reviewing CRF designs, database specs, edit checks, and clinical documents.
- Strong written and verbal communication skills with the ability to present statistical concepts clearly.
- Excellent organizational , problem-solving , and interpersonal skills.
- Demonstrated ability to lead CRO teams, and work both independently and collaboratively.
- Experience contributing to responses for regulatory submissions and health authority queries.
Preferred Attributes: - Ability to manage multiple tasks and adapt quickly to changes in project scope or timelines.
- Strong leadership in cross-functional settings, and comfort with mentoring and guiding team members.
- Keen attention to detail and quality-focused mindset.
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