The Principal Statistician drives the statistical strategy for one or more indications within a therapeutic area within Clinical Development to ensure robust, evidence-based decision making; operational and execution excellence – to enable seamless implementation of the drug development plans and for support of marketed products
He or she facilitates the discussion and ensures implementation of modern and innovative trial designs, statistical models, and analysis methodologies that optimize the drug development program in terms of risk, cost and timelines for each indication.
As a strategic partner she or he provides statistical strategies for clinical development plans and for global regulatory submissions and contribute to the drug development decisions with internal and external partners.
This role has global responsibilities with potential for matrix management, participation in global teams, and interacts with regulatory agencies in multiple countries.
Serves as a SME and lead biostatistics contributions to, and facilitate the direction of robust clinical development planning, seamlessly integrating all relevant technical and indication-specific knowledge
Provides statistical scientific consulting, and quantitative contributions to planning, execution and reporting of clinical trials and regulatory/submission strategy and related documents: (e.g.: SAP, Protocol, CSRs, integrated summaries, and responses to HA questions).
Actively participates in the SET/CDT (or equivalent) to provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximise probability of program success with objective and transparent clinical program assessments using quantitative risk/probability of success assessments.
Oversee production of, contribute to or prepare statistical sections of protocols, statistical analysis plans and CSRs. Generate and/or verify sample size calculations and randomization schemes as needed. Perform quality control checks of statistical analyses and SAS programs, as needed. Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
Provide technical statistical expertise and leadership within the framework of the indication. Analyse data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
Collaborate with, direct and monitor the work of CRO / statistical programming/ external consultants. Support and develop the relationships with CROs statistical functions. Perform acceptance checks of CRO/internal deliverables. Responsibility for statistical parts of CRO tendering process and work orders involving assigned therapeutic area.
Skills, Experience and Qualifications:
Advanced degree (PhD, or MS) in Statistics/Biostatistics (or equivalent).
At least 6 years of experiences in Clinical Development in a Pharmaceutical or Biotechnology setting. Knowledge of SAS/R and various sample size calculation software
Strong Technical statistical expertise and leadership within the framework of the indication.
Comprehensive understanding of study design and regulatory requirements necessary to deliver with high quality and on time.
Effective delivery of objectives in a complex matrix environment.
Ability to deal with rapid change.
Effective verbal & written communication skills in a cross functional environment.
Attention to detail.
Excellent project management skills.
Proactively owns and drives assigned tasks to completion.
Proactively develops solutions to complex issues.
Develops effective contingency plans.
Good negotiation skills with internal and external stakeholders.
Demonstrated ability to take measured risks with overall positive outcome for the business, seeking guidance where required.
Desirable to have an understanding of epidemiology, modern clinical safety and pharmacovigilance, pharmacokinetics and dynamics, assay development and validation
Internal Number: R-130330
About Seqirus - A CSL Company
Built on 100 years of experience in influenza, Seqirus is a new global company with an exciting future. It was created in 2015 when parent company CSL Limited acquired the Novartis Influenza Vaccine business and combined it with its own longstanding influenza vaccine operations. Seqirus is currently one of the world’s largest influenza vaccine company and a major partner in the prevention and control of influenza globally. It is a reliable supplier of influenza vaccine for Northern and Southern Hemisphere markets and a transcontinental partner in pandemic preparedness and response.
Seqirus operates state-of-the-art production facilities in the US, UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and commercial operations in more than 20 countries. In Australia and the Asia Pacific region, Seqirus is a leading provider of in-licensed vaccines and specialty pharmaceuticals. Seqirus is the sole supplier of a unique range of products made in the national interest for the Australian Government, including antivenoms and Q fever vaccine. Seqirus’ pare...nt company CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovative medicines. It operates in over 35 countries with more than 27,000 employees.
We invite you to take a look at the many career possibilities available around the globe and consider building a career that MAKES A DIFFERENCE. Become part of the Seqirus team today!
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