Principal Biostatistician

The primary purpose of thePrincipal Statisticianis to act independently as Study Statistician for complex work in an established area within clinical studies. This position may also act as Global Statistical Lead for an early or back up asset or as a Methodology expert validating the execution of complex techniques.

Responsibilities:

• Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact.
• Lead or provide the statistical input into the design of the program, protocol input such as study design, sample size calculations and patient randomization schemes and statistical aspects of case report form design
• Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
• Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports.
• Lead or supports responses to regulatory questions on the design of the program
• Ongoing coaching and mentorship of team members.

Key Requirements:

• PhD or M.S in Biostatistics, Statistics or related scientific field
• Significant experience in applying statistical methods in Pharma or CRO setting
• Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data
• Good ability in SAS required, knowledge of R preferred.
• Ability to understand, implement, and explain complex statistical methodology,
• Significant advantage: #oncology or #rarediseases

Further information:

• This is a permanent role and can be based inUK
• Remote based with ability to travel to the company's HQ - costs of travelling covered

If this opportunity is of interest, please apply now with your CV at your earliest availability. If further info needed, please feel free to connect with Catalin Zaharia.

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com