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 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 reviews and input to proposals.
• Maintains relevant project management activities on study such as financials and timelines with minimum support from Associate Director, Biostatistics.
• Supports the Associate Director, Biostatistics and other leadership in the review and development of controlled documents.
• Supports the Associate Director, Biostatistics and other leadership in interview process for potential employees, as needed.
• Acts as a senior reviewer and support for Biostatistics work performed at Ergomed.
• Plan, coordinate, and provide statistical analyses, summaries, and reports of studies in the support of product development including IND/NDA and BLA submissions, and IDE and PMA submissions.
• Keep up to date with industry best practices and techniques in clinical trial statistics and ensure colleagues are informed of any significant developments.

Qualifications

• Master's degree (or higher) in biostatistics, statistics, mathematics or other related disciplines. General understanding and application of biostatistics in clinical trials.
• Strong previous related experience working in a Contract Research Organization.
• Communication skills
• Presentation skills
• Knowledge of the MS Office Suite
• Proficiency in one or more statistical programming language (SAS Preferred).
• Collaboration across cross-functional teams
• Good understanding of ICH and regulatory landscape.
• Knowledge of advanced statistical methods (e.g., survival analysis, logistic regression, and mixed models)
• Fluency in English

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.

• Integrity and trust: we do the right thing, especially when it is hard.

• Drive and passion: we care about the outcome, because someone is waiting on it.

• Agility and responsiveness: we move quickly, because patients cannot wait.

• Belonging: everyone is welcome, and every voice counts.

• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.