Senior Biostatistician – Global Pharma (SME) – UK / Europe – Homebased
We have recently partnered exclusively with our client, an award winning pharma company focused on the patient centred drug development for the treatment of respiratory and special care (Cardiovascular) studies
They are looking for an experienced Biostatistician, who can provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs; provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables; provide/oversee statistics support to clinical trials, ensuring that data are collected, analyzed and evaluated with statistical rigor.
Your Key Tasks will include:
- Provides statistical input in support of Drug Development Programs
- Provides statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results
- Interacts with CROs and supervise statistical activitie
- Reviews/Develops the Statistical Analysis Plan, including the definition of derived data sets, and
- the design of statistical tables, figures, and data listings for clinical summary reports
- Plans and conducts statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies
- Conducts all the statistical activities for the Blind Review Meeting
- Reviews the Clinical Study Report
- Collaborates in writing regulatory document, reviews sections of regulatory submissions, attends meetings with regulatory agencies to support drug registration
- Manages the statistical deliverables required by eCTD submission
- Reviews abstracts, posters, presentations for publicationContributes to definition of SOPs
Previous experience in a similar job, in pharmaceutical company and/or Contract Research Organizations.
Reasons to join the team.
- Strong experience in clinical development
- In depth knowledge of statistical methods that apply to clinical trials: from first in human and PK studies, to phase II dose-finding and pivotal studies. Knowledge on RWE studies a benefit
- Experience of regulatory interactions and submissions
- Excellent knowledge of international standards (CDISC SDTM or ADaM)
- Good knowledge of regulatory guidelines and requirements for data submission in different geographical areas (US, China, Japan)
- Good SAS programming skills. Knowledge of R programming is a plus
What you get in return
- Real investment in innovation – Company evolution
- Work from human through to phase III and other departments, so strong focus on growth
- Excellent team and people management development
- 20% of their revenue spent on research.
- Patient centric company
- Winner of top employee EU/US
- They are in an evolutionary, with a strong investment in innovation
- There is room to influence the company and grow.
- They are team orientated.
- 20% of revenue is invested on research, the patient is most important.
What to do next:
- Ongoing development is vital, and as a valued Biostatistician you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
- In comparison with their competitor’s and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in industry.
- They also provide successful candidates with an excellent employment package and benefits adapted to the current job market.
If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.
Not what you’re looking for? Please contact Aimee Weston on 07806 790645 for a confidential discussion about potential opportunities.