Company: Confidential
Job Title: Dir./Sr. Dir. Biostatistics.
Job Number: 87704
Location: , US
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#LI-DNI
Application Deadline: 2024-12-30
To apply for this job please visit jobrxiv.org.