Head of Biostatistics

Head of Biostatistics:

Location: 100% remote is possible for European Citizens

Job Title: This role can be titled from Director to Head of Biostatistics dependant on experience for the candidate.

The Company:
A Swiss speciality pharmaceutical company focused on the development and commercialisation of innovative medicines for rare diseases with high unmet medical need. With a product rapidly approaching launch, and more in the pipeline they are going through an exciting period of growth.
Due to the company size this is an excellent opportunity for anyone who is motivated to make a key impact on both the company and the patients.

The Role:
Lead the Biostatistics team and ensure the effective application of statistical methodologies across the company’s drug development initiatives, encompassing pre-clinical and clinical development, worldwide product registration, market access, medical marketing, and life-cycle management.

Main responsibilities:

• Lead the successful utilisation of statistical methods in the company’s development programs.
• Manage an external Biostatistics team, and help built the internal team within the first few months of joining from the ground up
• Create and take the lead on outsourcing strategy for biostatistics activities and ensure proper supervision.
• Review and approve essential study-level documents (e.g., clinical study protocols, statistical analysis plans, clinical study reports) as well as project-level documents (e.g., clinical development plans, target product profiles).
• Contribute to the regulatory strategy for global regulatory submissions.
• Participate in global meetings and engage with regulatory authorities in the capacity of an expert statistician.
• Provide input and review relevant sections of global regulatory submissions, such as documents within Module 2 of the dossiers.
• Develop the processes and operating procedures related to statistical programming and statistics.
• Collaborate within a matrix structure with multiple teams

About you:

• Hold a Master’s degree or higher in statistics or life sciences.
• 7 years + experience as a clinical data analyst/statistician in either a pharmaceutical company or Contract Research Organization (CRO).
• Demonstrated experience in global regulatory submissions.
• Familiarity with the role of statistics in supporting market access, medical marketing, and the life-cycle management of products.
• Expertise in working with both study-level documents (e.g., clinical study protocols, statistical analysis plans, clinical study reports) and project-level documents (e.g., clinical development plans, target product profiles).
• In-depth understanding of statistical methods commonly used in clinical development and the ability to implement innovative methodologies.
• Exceptional proficiency in written and spoken English, any other language is a bonus
• Strong communication skills.

“I’m interested, what’s next?”

• If you have a copy of a recent CV to hand, please hit the apply button!
• If you don’t have a CV ready but would like to know more, please drop me a Linkedin Message https://www.linkedin.com/in/ed-hobbs-72ba5874/