Principal Biostatistician

Principal Biostatistician

The Principal Biostatistician is responsible for the design, analysis, and/or interpretation of clinical studies as a lead (or contributing team members) for clinical studies. In this role, the Principal Biostatistician will be part of a collaborative team that works with the sponsor, PM, clinical team, data managers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies).

The biostatistician is responsible for (or participates in) the creation, review, maintenance, and oversight of all contracted statistical output and activities. These responsibilities may include, but are not limited to, relevant sections of the clinical protocol, the statistical analysis plan, data/safety review meetings, content development specifications, and review (or input into) relevant sections of summary reports.

Role and Responsibilities

• Maintains responsibility for all assigned duties within a clinical study, this may include:
• Act as the study lead for multiple studies, clinical programs, and/or large/complex studies with responsibility for all biostatistics related activities.
• Support the review and development of clinical programs; may contribute to complex methods and analysis sections of protocols as well as support the review of design; able to provide feedback regarding issues or improvements to initial proposed designs.
• May involve oversight of the statistical programming activities.
• Ensuring that work is performed on time.
• Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality.
• Provide review and oversight to statistical output created by other members of the biostatistics department
• Review protocols, synopses, and other statistical documents for a study and provide feedback and consult.
• Research, or otherwise support, trial design and consultative activities
• Review relevant content from other functional areas (e.g., Case Report Forms) on behalf of the biostatistics team
• Write summaries of findings and results to be included as part of study reports such as for interim analyses or the final CSR.
• Writing or reviewing some, or all, of the Statistical Analysis Plan and corresponding output shells
• Providing relevant specifications/guidance for complex and/or pivotal outputs
• Works with other study team members (both internal and external) to represent the needs and input of the statistical components of the study
• Reviewing output (TLFs, SDTM and ADaM datasets, SDTM and ADaM specifications) developed by statistical programmers and/or other statisticians for quality, validity, and appropriateness
• Provides mentoring and support to more junior statisticians
• Represent the function in internal and external meetings for assigned studies.
• Represent the function in audits of study activity.
• Represent the function in bid defenses and other sales related activities.

Qualifications

• Master's degree (or Higher) in biostatistics, statistics, mathematics or other related disciplines. General understanding and application of biostatistics in clinical trials.
• Strong related experience working in a Contract Research Organization.
• Proficiency in one or more statistical programming language (SAS and R preferred).

Additional Information

The position is also available in any of our European locations

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships
• We look forward to welcoming your application.