Principal Biostatistician

Company Description

Medicine moves forward here. So will you. 

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.  

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. 

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. 

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

The position is also available in any of our European locations

Job Description

The Principal Biostatistician is responsible for the design, analysis, and/or interpretation of clinical 
studies as a lead (or contributing team member) 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 Principal 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.
• Provides departmental training and participates in cross-functional initiatives as a representative of the department, as needed.
• 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.
• Supports the Associate Director, Biostatistics and other leadership in budget review