Paul de Challans is recruiting for a statistician to join a company in the pharmaceutical industry at their site based in Hertfordshire on a contract basis.
The main purpose of the role will be: Clinical Development:
- Member of 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.
- Overseeing the deliverables from Statistical CROs.
- Leading cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
Participating in health authority meetings Nonclinical Statistics
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.
- Functional Area:
- Understand and apply business requirements and processes. Participates in functional training.
- Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
- Participates in Biostatistics and cross-functional initiatives. Participates in the development of functional processes
Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications. People Development and Management:
Mentor other statisticians on request
In order to be considered for this role, you will be 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
- Good knowledge of theoretical and applied statistics
- Very good knowledge and experience applying statistical methods to drug development
- Good understanding of regulatory guidelines in a pharmaceutical research setting
- Understands and applies Business requirements and processes
- Understands and respects cultural differences when interacting with colleagues in the global work place
- 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.
This is an excellent opportunity to join a global pharmaceutical company
To apply for this position, please contact Paul De Challans on 0114 283 9956 or email firstname.lastname@example.org. Alternatively, click on the link below.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30026 in all correspondence.