Principal Statistician | Senior Principal Biostatistician (W2 Only)
Job Summary: The Senior Manager ā 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:
ā¢ Review clinical trial protocols and contribute to the design of study elements, including sample size calculations, statistical methodology, and timelines.
ā¢ Author and/or review statistical sections of protocols, SAPs, TFL shells, and variable derivation specifications.
ā¢ Review CRFs, database design, and edit check specifications to ensure data integrity and consistency.
ā¢ Monitor study conduct, quality surveillance plans, and data quality throughout the trial.
ā¢ Provide statistical and validation support for data analyses, including analysis datasets and TFLs.
ā¢ Review and contribute to clinical study reports (CSRs), manuscripts, and other statistical documentation.
ā¢ Participate in the preparation of responses to health authorities and perform ad-hoc analyses as required.
ā¢ Provide statistical input to regulatory documents and filings.
ā¢ Collaborate effectively with cross-functional teams, CRO statisticians, statistical programmers, and vendors.
ā¢ Track and manage timelines related to statistical deliverables, proactively mitigating risks.
ā¢ Lead CRO statistical teams, review their deliverables, and ensure compliance with quality standards.
Required Qualifications:
ā¢ Ph.D. in Statistics or Biostatistics with 4+ years of experience, or MS with 6+ years in the pharmaceutical or CRO industry.
ā¢ Proficiency in SAS programming and statistical software.
ā¢ Strong knowledge of industry standards including ICH guidelines, CDISC data structures, and FDA statistical requirements.
ā¢ Proven experience in reviewing CRF designs, database specs, edit checks, and clinical documents.
ā¢ Strong written and verbal communication skills with the ability to present statistical concepts clearly.
ā¢ Excellent organizational, problem-solving, and interpersonal skills.
ā¢ Demonstrated ability to lead CRO teams, and work both independently and collaboratively.
ā¢ Experience contributing to responses for regulatory submissions and health authority queries.
Preferred Attributes:
ā¢ Ability to manage multiple tasks and adapt quickly to changes in project scope or timelines.
ā¢ Strong leadership in cross-functional settings, and comfort with mentoring and guiding team members.
ā¢ Keen attention to detail and quality-focused mindset.
ā¢ Review clinical trial protocols and contribute to the design of study elements, including sample size calculations, statistical methodology, and timelines.
ā¢ Author and/or review statistical sections of protocols, SAPs, TFL shells, and variable derivation specifications.
ā¢ Review CRFs, database design, and edit check specifications to ensure data integrity and consistency.
ā¢ Monitor study conduct, quality surveillance plans, and data quality throughout the trial.
ā¢ Provide statistical and validation support for data analyses, including analysis datasets and TFLs.
ā¢ Review and contribute to clinical study reports (CSRs), manuscripts, and other statistical documentation.
ā¢ Participate in the preparation of responses to health authorities and perform ad-hoc analyses as required.
ā¢ Provide statistical input to regulatory documents and filings.
ā¢ Collaborate effectively with cross-functional teams, CRO statisticians, statistical programmers, and vendors.
ā¢ Track and manage timelines related to statistical deliverables, proactively mitigating risks.
ā¢ Lead CRO statistical teams, review their deliverables, and ensure compliance with quality standards.
Required Qualifications:
ā¢ Ph.D. in Statistics or Biostatistics with 4+ years of experience, or MS with 6+ years in the pharmaceutical or CRO industry.
ā¢ Proficiency in SAS programming and statistical software.
ā¢ Strong knowledge of industry standards including ICH guidelines, CDISC data structures, and FDA statistical requirements.
ā¢ Proven experience in reviewing CRF designs, database specs, edit checks, and clinical documents.
ā¢ Strong written and verbal communication skills with the ability to present statistical concepts clearly.
ā¢ Excellent organizational, problem-solving, and interpersonal skills.
ā¢ Demonstrated ability to lead CRO teams, and work both independently and collaboratively.
ā¢ Experience contributing to responses for regulatory submissions and health authority queries.
Preferred Attributes:
ā¢ Ability to manage multiple tasks and adapt quickly to changes in project scope or timelines.
ā¢ Strong leadership in cross-functional settings, and comfort with mentoring and guiding team members.
ā¢ Keen attention to detail and quality-focused mindset.