Job Description
This a Full Remote job, the offer is available from: New Jersey (USA)
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.
This offer from "MDA Edge" has been enriched by Jobgether.com and got a 75% flex score.
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