|Location:||Middlesex County, Parkville, Union County|
|Job Type:||Full Time|
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
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.
Responsibilities include: -
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
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
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.
Support and lead infrastructure / process / scientific consulting improvement initiatives and
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