Senior Director, Biostatistics — Lead Clinical Data Strategy

ptcbio; New Jersey; Hybrid; USD 239.000 - 281.000; Vollzeit

Benefits dieser Stelle

Short- and long-term incentives

Medical, dental, vision coverage

Retirement savings plans

Zusammenfassung

PTC Therapeutics is seeking a Senior Director, Biostatistics to provide technical leadership and oversight for clinical development programs across assigned therapeutic areas.

The role involves designing studies, defining data analysis strategies, authoring analysis plans, and communicating findings to internal teams and key external stakeholders. Interaction with regulatory agencies is possible.

Qualifikationen

• Advanced degree in Statistics or a related statistical discipline and a minimum of 12 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO).
• Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies.
• Demonstrated understanding and working knowledge of advanced statistical theory and its application in the pharmaceutical/biotechnology industry.
• Prior BLA, NDA and/or MAA experience is highly desirable

Aufgaben

• Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material.
• Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally.
• Participates in vendor evaluation, selection, and management.
• Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
• Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions.
• Authors and reviews statistical and outcome sections of study reports and submissions.
• Provide support on statistical deliverable for NDAs/BLAs and other submissions
• Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as needed.
• Performs other tasks and assignments as needed and specified by management.

Kenntnisse

Clinical statistics

Regulatory interaction

Cross-functional collaboration

Communication skills

Problem solving

Ausbildung

Advanced degree in Statistics

Jobbeschreibung

PTC Therapeutics is seeking a Senior Director, Biostatistics to provide technical leadership and oversight for clinical development programs across assigned therapeutic areas.

The role involves designing studies, defining data analysis strategies, authoring analysis plans, and communicating findings to internal teams and key external stakeholders. Interaction with regulatory agencies is possible.