Company: Confidential
Job Title: Dir./Sr. Dir. Biostatistics.
Job Number: 35307
Location: ,
Job Description
In this role, reporting to the VP of Biometrics, you will work with cross-functional clinical teams, overseeing statistical activities and managing outsourced deliverables. This position offers the chance to impact the development of transformative therapies. Strong communication, collaboration, and self-motivation are key.
Responsibilities
- Serve as a biostatistics expert for clinical programs.
- Provide strategic input on trial designs for early and late-phase studies.
- Collaborate with internal and CRO teams on statistical deliverables.
- Conduct statistical modeling to optimize designs and address issues.
- Contribute to clinical protocol development and statistical analysis plans.
- Oversee development of tables, figures, and listings for trials.
- Ensure eCRF designs meet analysis requirements.
- Support regulatory submissions and address agency questions.
- Contribute to publications and represent the company externally.
- Lead process improvement for Biostatistics.
- Support inspection readiness and maintain advanced statistical skills.
- Perform additional duties as needed.
Required Skills
- PhD in statistics or related field; or MS with relevant experience
- 8+ years in the pharmaceutical or biotech industry
- Experience in clinical trial design, analysis, and reporting
- Familiarity with INDs, NDAs, MAAs, or regulatory submissions
- Strong knowledge of clinical trial statistical methods and regulations
- Proficient in SAS and R programming
- Ability to lead statistical efforts across multiple studies
- Knowledge of data standards like SDTM and ADaM
- Experience with outsourced CRO statistical services
- Independent, proactive problem solver
- Strong written and oral communication skills, especially in conveying statistical concepts
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