Sr Principal Statistician
Jazz Pharmaceuticals
6 months ago
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Brief Description
- Lead biostatistics on individual studies, related studies, and integrated summaries; design and report Phase I–IV clinical studies and regulatory filings under supervision of a more senior statistician.
- Responsible for statistical aspects of study design, study analysis and validation, and study documentation.
- Provide timely, scientifically sound statistical expertise; develop and execute statistical strategy, design, and analyses for clinical trials.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
- Manage statistics and programming work done by external vendors.
Essential Functions
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate to meet recurring report timelines.
- Support development and implementation of study protocols.
- Review and provide input to data capture systems and participate in their validation.
- Develop statistical programs to simulate operating characteristics, perform analyses, prepare data displays, and verify analysis accuracy/validity.
- Write/review statistical analysis plans; perform/oversee data analysis and validation; interpret analyses.
- Prepare for and attend meetings with regulatory agencies.
- Work with biostatistics compound/therapeutic area lead and peers to develop/maintain department standards and practices.
- Review timelines and analysis plans for CRO work; ensure timeliness and quality.
- Review and validate CRO deliverables.
- Act as statistical SME for clinical reports, integrated summaries, and related documents with medical writers.
- Respond to statistical questions from regulatory agencies.
Required Knowledge, Skills, and Abilities
- Clinical trial design and analysis (complex statistical methods/models; inference/hypothesis testing; parametric/non-parametric methods; sample size principles; design of experiments; Phase II–IV data analysis).
- SAS and R experience; other statistical applications/programming languages a plus.
- Knowledge of regulatory requirements/guidelines (e.g., ICH) and statistical contributions to marketing applications and CDISC standards.
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Excellent written and verbal communication and interpersonal skills.
- Strong attention to detail; flexible/positive/creative thinker.
- Work without close supervision; strong time management.
Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or related field with statistical focus; >4 years pharma/biotech experience.
- PhD in statistics, mathematics, or related field with statistical focus; >2 years pharma/biotech experience.
- Knowledge of drug development regulations pertinent to statistical analysis.
- Oncology or hematology therapeutic area knowledge (preferred).
- Bayesian and adaptive design experience (preferred).
- Proficient SAS & R; solid understanding of CDISC models/standards.
- Excellent writing/communication; demonstrated leadership.
Benefits (US)
- Medical, dental, and vision insurance; 401(k) retirement savings plan; flexible paid vacation.
Application Instruction (as stated)
- If you are a current Jazz employee, apply via the Internal Career site.
- Lead biostatistics on individual studies, related studies, and integrated summaries; design and report Phase I–IV clinical studies and regulatory filings under supervision of a more senior statistician.
- Responsible for statistical aspects of study design, study analysis and validation, and study documentation.
- Provide timely, scientifically sound statistical expertise; develop and execute statistical strategy, design, and analyses for clinical trials.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
- Manage statistics and programming work done by external vendors.
Essential Functions
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate to meet recurring report timelines.
- Support development and implementation of study protocols.
- Review and provide input to data capture systems and participate in their validation.
- Develop statistical programs to simulate operating characteristics, perform analyses, prepare data displays, and verify analysis accuracy/validity.
- Write/review statistical analysis plans; perform/oversee data analysis and validation; interpret analyses.
- Prepare for and attend meetings with regulatory agencies.
- Work with biostatistics compound/therapeutic area lead and peers to develop/maintain department standards and practices.
- Review timelines and analysis plans for CRO work; ensure timeliness and quality.
- Review and validate CRO deliverables.
- Act as statistical SME for clinical reports, integrated summaries, and related documents with medical writers.
- Respond to statistical questions from regulatory agencies.
Required Knowledge, Skills, and Abilities
- Clinical trial design and analysis (complex statistical methods/models; inference/hypothesis testing; parametric/non-parametric methods; sample size principles; design of experiments; Phase II–IV data analysis).
- SAS and R experience; other statistical applications/programming languages a plus.
- Knowledge of regulatory requirements/guidelines (e.g., ICH) and statistical contributions to marketing applications and CDISC standards.
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Excellent written and verbal communication and interpersonal skills.
- Strong attention to detail; flexible/positive/creative thinker.
- Work without close supervision; strong time management.
Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or related field with statistical focus; >4 years pharma/biotech experience.
- PhD in statistics, mathematics, or related field with statistical focus; >2 years pharma/biotech experience.
- Knowledge of drug development regulations pertinent to statistical analysis.
- Oncology or hematology therapeutic area knowledge (preferred).
- Bayesian and adaptive design experience (preferred).
- Proficient SAS & R; solid understanding of CDISC models/standards.
- Excellent writing/communication; demonstrated leadership.
Benefits (US)
- Medical, dental, and vision insurance; 401(k) retirement savings plan; flexible paid vacation.
Application Instruction (as stated)
- If you are a current Jazz employee, apply via the Internal Career site.