Job Description
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Role Description
- This role offers an opportunity to lead critical statistical activities supporting the development of innovative pharmaceutical products across multiple clinical programs. The Associate Director will oversee biostatistical strategy and vendor-delivered statistical programming while ensuring high-quality analysis aligned with regulatory standards and project timelines. Working closely with cross-functional teams including clinical development, data management, and external research partners, you will contribute to study design, protocol development, and the interpretation of complex clinical data. This position plays a key role in shaping statistical approaches across the drug development lifecycle while ensuring data integrity and scientific rigor. The role is ideal for an experienced biostatistics professional who thrives in collaborative environments and enjoys translating data into actionable insights that advance clinical research. Candidates will have the opportunity to influence study outcomes and support regulatory submissions in a fast-paced, innovation-driven setting.
- Lead and oversee biostatistical activities for clinical development programs, ensuring alignment with study timelines, budgets, and regulatory requirements.
- Conduct statistical analyses according to predefined statistical analysis plans, generating insights that support clinical study conclusions.
- Develop sample size calculations, power analyses, and randomization strategies for clinical studies.
- Oversee external CRO partners responsible for statistical programming and analysis deliverables, ensuring accuracy, data quality, and adherence to timelines.
- Independently program or validate key study outputs such as tables, figures, and listings to support data interpretation.
- Collaborate with data management teams to review datasets, assist with data cleaning activities, and contribute to data-related documentation.
- Ensure clinical datasets and outputs comply with regulatory requirements, CDISC standards, and industry best practices.
- Support the preparation of clinical study reports, regulatory submissions, and scientific publications including abstracts, manuscripts, and conference presentations.
- Work closely with multidisciplinary teams to communicate statistical findings and support the interpretation of clinical data.
- Qualifications
- Master’s degree (MS or MPH) in Biostatistics, Statistics, Epidemiology, or a related quantitative discipline.
- At least 6 years of experience in clinical trial biostatistics or statistical programming within the pharmaceutical, biotechnology, or CRO industry.
- Experience supporting clinical development programs across Phase I–III trials.
- Strong understanding of statistical methodologies commonly used in clinical trial data analysis.
- Proficiency in SAS programming; experience with R is considered an advantage.
- Working knowledge of CDISC standards and familiarity with electronic data capture systems.
- Experience performing sample size and power calculations using software such as nQuery or PASS is preferred.
- Understanding of real-world data analysis and observational study design is a plus.
- Excellent analytical, communication, and collaboration skills with the ability to explain statistical findings to non-statistical stakeholders.
- Strong organizational skills, attention to detail, and the ability to manage multiple projects in a dynamic environment.
- Benefits
- Competitive base salary ranging approximately from $140,000 to $240,000 depending on experience and location.
- Eligibility for performance-based bonuses and equity compensation.
- Comprehensive health, dental, and vision insurance plans.
- Retirement savings plans with employer contributions.
- Generous paid time off, holidays, and additional leave benefits.
- Flexible work arrangements including remote or hybrid options depending on location.
- Professional development and career growth opportunities.
- Travel opportunities for collaboration, scientific meetings, and industry engagement.
Company Description
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