Hi Allstat,

 

SRG Clinical are looking for a Principal Statistician to join our client- a global CRO. We are looking for an experienced Statistician with strong leadership skills

working on Phase I-IV drug development projects in a variety of therapeutic areas such as Oncology, CNS or Cardiovascular.

 

 

PRINCIPAL STATISTICIAN

PERMANENT

INTERNATIONAL CRO

EAST MIDLANDS

COMPETITIVE SALARY & BENEFITS

 

 

Key Responsibilities

 

·         Manage the statistics support to one or more projects/sponsor programmes of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.

·         Provides expert review of study designs, analysis plans and reports.

·         Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing statistical analysis plans.

·         Provide project support to the statistics reporting process through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.

·         Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation.

·         Facilitate department knowledge of the latest developments in statistical methods, regulations (in particular ICH, FDA, CPMP points to consider efficacy, safety and quality standards) and software applications.

·         Lead the development of statistical design and analysis policies.

·         Perform lead role in identifying system and process improvements, and to develop and implement solutions to Improve the efficiency and quality of clinical study data processing and reporting.

·         Provide consultancy, mentoring and guidance to statisticians on statistical methodological issues during trial design and analysis of clinical trial data.

·         Assist the Director of Biostatistics with all other aspects of the job as required.

 

 

Minimum Requirements

 

·         BSc/MSc or scientific discipline or equivalent

·         Must have industry experience

·         Extensive hands-on Statistical experience

·         Knowledge of different phases and types of clinical trial reporting (e.g Phase I-IV, Clinical Study Reporting, ISS/ISE including e-sub activities)

·         Excellent understanding of skills and goals of reporting clinical data

·         Good knowledge of SAS, SQL and Unix

·         Prior experience of training and mentoring of others in this field

·         Demonstrated ability to manage own and other people’s workloads

·         Broad understanding of statistical methods within the context of clinical and/or clinical pharmacology trials

 

If you like to receive more information or apply for this position then please send an updated version of your cv to

[log in to unmask] or alternatively call me on +44 (0) 203 096 47 01

 

Best regards

Sabrina Andresen

Biometrics Recruiter for SRG Clinical

+44 (0) 203 096 47 01

 

Follow me on LinkedIn  https://uk.linkedin.com/in/sabrinandresen