Principal biostatistics lead

SUMMARY

This is not a typical study-level role — you’ll act as the indication expert across a multi-asset portfolio, shaping how statistical strategy is designed, executed, and communicated.

You’ll play a key role in innovative trial design (including adaptive & Bayesian approaches) and support late-stage development, regulatory submissions, and approvals, while acting as a strategic partner to senior leadership.

RESPONSIBILITIES

• Lead programme/indication-level statistical strategy across multiple clinical assets
• Design and drive innovative trial methodologies (adaptive designs, Bayesian approaches)
• Partner with cross-functional teams to support global clinical development plans
• Contribute to regulatory submissions (BLA/NDA/MAA) and health authority interactions
• Act as a key liaison between statistical teams, leadership, and broader stakeholders
• Ensure high-quality statistical deliverables to support late-stage development and approvals
• Mentor and support statisticians within a matrix environment

QUALIFICATIONS

• Strong experience in programme or indication-level leadership (beyond single-study scope)
• Proven track record in clinical trial design across phases I–IV
• Experience with adaptive and/or Bayesian statistical methods
• Solid exposure to global regulatory submissions and agency interactions
• Proficiency in SAS and/or R
• Ability to clearly communicate complex statistical concepts
• MSc or PhD in Statistics (or related field) with 7+ years in pharma/biotech
• Experience in rare disease / autoimmune settings is advantageous

This job title is not an exact reflection of the exact job title at this client. This client uses specific titles, often not reflective of seniority, and the title used is purely to give an indication to applicants as to the approximate leveling on the market. Your Planet Pharma Recruiter will be able to provide the exact title and grading upon application.

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters 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 recognized 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

TO APPLY

Please click ‘apply’ or contact Joesela Alolod A. (Recruitment Sourcer) at Planet Pharma for more information:

E:

T: +61 370580550

Linkedin: www.linkedin.com/in/joeselaaloloda/