Principal Statistician | Senior Principal Biostatistician (W2 Only)

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.