Associate Director – Biostatistics

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Serve as the statistical lead on a drug development project or individual clinical trials at Jazz Pharmaceuticals.

• Design and report on Phase I to IV clinical studies and regulatory submissions.

• Take ownership of the statistical components of study design, analysis, validation, and documentation.

• Formulate and implement statistical strategies, designs, and analyses for clinical trials.

• Collaborate effectively with clinicians, data managers, biostatisticians, and statistical programmers.

• Lead or assist in providing statistical input and strategies during governance team discussions.

• Contribute to or spearhead departmental processes, procedures, standards, and operational protocols.

• Oversee the work carried out by external statistics and programming vendors.

• Supervise the professional growth of direct reports.

• Participate in or lead departmental and cross-functional meetings aimed at optimizing study designs, endpoints, and analysis strategies.

• Create or review statistical analysis plans and interpret data effectively.

• Develop statistical programs to simulate the operating characteristics of clinical trials, perform analyses, prepare data displays, and ensure data accuracy and analytical validity.

• Contribute to or lead Biometrics teams in establishing, implementing, and maintaining standards and practices.

• Attend meetings with regulatory agencies and address statistical inquiries.

• Collaborate with researchers and thought leaders on clinical development projects and publications.

• Present study findings to both internal and external audiences.

• Conduct independent research and address statistical methodological challenges.

• Recruit, mentor, and oversee both internal and external statisticians.

⛳️ Requirements

• PhD with over 4 years of experience or MS with more than 6 years of experience.

• Degree in statistics, mathematics, or a related field with a statistical emphasis.

• Proficient knowledge of clinical trial design and analysis, including complex statistical methods and models.

• Strong knowledge and experience in the Oncology therapeutic area.

• Familiarity with SAS or R programming languages.

• In-depth understanding of relevant regulatory requirements and guidelines, including ICH Guidelines.

• Knowledge of CDISC SDTM and ADaM standards.

• Experience contributing to NDA or BLA submissions and their defense.

• Proficient in SAS programming.

• Comprehensive understanding of CDISC models and standards.

• Excellent writing and communication skills.

• Proven leadership qualities and exceptional interpersonal skills.

• Experience with Bayesian and adaptive designs is preferred.

• Familiarity with the oncology or hematology therapeutic area is preferred.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.