Associate Director, Biostatistics

Initial Therapeutics, Inc.; Deutschland; Remote; EUR 148.000 - 222.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision insurance

401(k) retirement plan

Discretionary bonus

Zusammenfassung

Jazz Pharmaceuticals, Inc. is seeking an Associate Director, Biostatistics to serve as the statistical lead on drug development projects and clinical trials from Phase I to IV. You will design, analyze, and validate studies, working with clinicians, data managers, statisticians, and programmers.

This role may lead teams and engage with regulatory bodies. You will guide statistical strategy, contribute to regulatory submissions, and oversee vendor work while mentoring staff in a fast-paced

Qualifikationen

• PhD with >4 years of experience or MS with >6 years of experience.
• Degree in statistics, mathematics, or a related discipline with a statistical focus.
• Strong knowledge of clinical trial design and statistical applications for clinical trials.
• Expert knowledge of drug development regulations pertinent to statistical analysis.

Aufgaben

• Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Lead, develop and execute statistical strategy, design, and analyses for clinical trials within a project(s).
• Develop or review statistical analysis plans and interpret data.
• Develop statistical programs to simulate trial design operating characteristics and verify analyses.
• Contribute to or lead Biometrics teams to develop and maintain standards.
• Attend meetings with regulatory agencies; respond to statistical questions from regulators.
• Collaborate with researchers to plan development projects and publications where appropriate.
• Present study results to internal and external audiences.
• Conduct independent research and resolve statistical methodological issues.
• Recruit, develop and supervise internal and external statisticians.

Kenntnisse

Clinical trial design

Oncology

SAS

R

Regulatory knowledge

Ausbildung

PhD +4+ years

MS +6+ years

Statistics/Mathematics degree

Tools

CDISC SDTM/ADaM

Jobbeschreibung

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate totransform the lives of patients and their families. We are dedicated to developinglife-changing medicines for people with serious diseases — often with limited or notherapeutic options. We have a diverse portfolio of marketed medicines, including leadingtherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.Our patient-focused and science-driven approach powers pioneering research and developmentadvancements across our robust pipeline of innovative therapeutics in oncology andneuroscience. Jazz is headquartered in Dublin, Ireland with research and developmentlaboratories, manufacturing facilities and employees in multiple countries committed toserving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

The Associate Director, Biostatistics will function as the statistical lead on a Jazz Pharmaceuticals drug development project or as the statistical lead for individual clinical trials, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings. This position may have direct reports. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation. The Associate Director will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. The incumbent will work collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers to plan, conduct, and analyze clinical studies, including integrated reporting. Lead (if the statistical lead on a clinical development project) or support (if the statistical lead for individual clinical trials) statistical input and strategy in governance team discussions. Contributes to or leads the development of departmental processes and procedures, including establishing standards and operating procedures. The Associate Director will manage work done by statistics and programming external vendors. Oversees professional development of any direct reports.

Essential Functions

• Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Lead, develop and execute statistical strategy, design, and analyses for clinical trials within a project(s)
• Develop or review statistical analysis plans and interpret data.
• Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming
• Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.
• Attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies.
• Collaborate with researchers and thought leaders to plan clinical development projects and, if appropriate, publications of study results.
• Present study results to internal and external audiences
• Be able to conduct independent research and resolve statistical methodological issues
• Recruit, develop and supervise internal and external statisticians.

Required Knowledge, Skills, and Abilities

• Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
• Good knowledge and experience working in Oncology therapeutic area
• Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus.
• Thorough knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.

• Able to work in a fast-paced, flexible, team-oriented environment.

• Possess excellent interpersonal and communication skills (written and verbal).

• Strong attention to detail.

• Flexible, positive, creative thinker, good communicator.

• Work without close supervision. Time management skills are important.

Required/Preferred Education and Licenses

• PhD with > 4 years of experience or MS with > 6 years of experience
• Degree in statistics, mathematics, or a related discipline with a statistical focus.
• Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials.
• Expert knowledge of drug development regulations pertinent to statistical analysis.
• Knowledge of the oncology or hematology therapeutic area is preferred.
• Bayesian and adaptive design experience is preferred.
• Experience in contributing to NDA or BLA submissions and defense.
• Proficient SAS programming skills, comprehensive understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $172,000.00 - $258,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.