Dear ALLSTAT,

 

Senior Biostatistician– UK

 

•           Jessica Todd at CK Clinical

•           Senior Biostatistician

•           UK

•           Global Pharmaceutical company

•           Contract – office based but 1-2 days home-based accommodated.

 

The main responsibilities of this role are:

 

·         Study Planning: Provides experimental design and analysis strategies to nonclinical projects.

·         Analysis and Reporting: Performs statistical analyses for nonclinical studies, provides input to IND and BLA submissions and to regulatory response to global health authority investigations related to marketed products, and contributes to publications and presentations.

·         Statistical Consulting: Provides statistical advice to nonclinical investigators and contributes to the development of statistics courses.

 

Further responsibilities of the role :

 

·         As a  Member of the clinical team:

Collaborating in preparation of Clinical Development Plans and target product profiles; typically lead statistician on cross-functional study management teams or sole statistician on early development project teams

·         Study Planning: Reviews study protocols, authors statistical sections of protocols, prepares the study randomization, develops the statistical and data analysis plans, develops independent data monitoring and endpoint committee charters.

·         Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, review and approve analyses produced by statistical programming

·         Analysis & Reporting: Authors the clinical study report, provides input into global health authority documents and regulatory response for health authority submissions. Contributes to study publications and presentations.

·         Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.

·         Oversees the deliverables from Statistical CROs.

·         Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation

·         Participates in health authority meetings

 

You are required to have the following qualifications, skills and experience:

 

·         MSc or PhD in statistics, biostatistics, mathematics or similar areas of academic discipline.

·         Good knowledge of English in a business environment.

·         Experience in using statistical software

·         Accomplishes responsibilities with little supervision

·         Effective Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)

·         Good Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors)

·         Good Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects)

·          Evident Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)

·         Effective mentoring other statisticians.

 

For more information, contact me on 01438 842976 or email [log in to unmask] with an updated CV for a quick response.

 

 

Kind regards,

 

Jessica Todd BA

Consultant - Biometrics

CK Clinical Limited

9 High Street

Stevenage

SG1 3BG

DD: 01438 842976

T: 01438 743047

F: 01438 723800

W: www.ckclinical.co.uk / www.ckmedics.com

 

We are part of CKA Group – Winner of Kelly Services 2012 Global Supplier Excellence Award

 

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