Lead Biostatistical Analyst

1 week ago


Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time

Overview:


As a Lead Biostatistical Analyst, you will become a vital part of a premier clinical research organization, driven by advanced healthcare insights.


Responsibilities:

Your Role:
Ability to undertake the Study Statistician responsibilities with minimal oversight.

Exhibits profound statistical knowledge with a solid grasp of intricate experimental designs and inference techniques (including familiarity with Bayesian methods, Futility analysis, Predictive Inference, Estimands, and handling Missing Data, where applicable).

When necessary, actively engages in cross-functional team discussions.

Implements standardized procedures to tasks, ensuring deliverables are precise, of high quality, and completed within agreed timelines.

Possesses extensive knowledge of GxP, ICH guidelines, internal processes, and relevant external regulations.

Conducts Quality Control (QC) of colleagues' work under guidance.

Under Guidance:

  • Assists in the design, analysis, and interpretation, utilizing a broad spectrum of statistical methodologies and/or relevant software to evaluate options.
  • Drafts analysis plans and prepares statistical contributions for key documents and presentation materials.
  • Participates in formulating statistical strategies at the study level, which may be communicated to stakeholders.

Qualifications:

Ideal Candidate:
Master's degree in statistics or biostatistics is essential.

A minimum of 8 years of experience in biostatistics is preferred.

Clinical experience is required.

Demonstrates proficiency in various statistical domains, the drug development lifecycle, SAS methodologies, and sound programming practices.

Thorough understanding of and experience with CDISC standards is advantageous.

Proven ability to plan, oversee, implement, and monitor statistical processes for multiple clinical trials.

Familiarity with ICH-GCP and other relevant regulations is necessary for successful execution of clinical studies.

Experience in auto-immune and/or oncology clinical studies is a plus.

Vendor management experience is beneficial.

Why Pharmaceutical Research Associates, Inc?


We prioritize providing a comprehensive and competitive total rewards package that includes not only an attractive base salary but also a variety of variable pay and recognition programs.

Moreover, our exceptional employee benefits, supportive policies, and wellness initiatives are designed to assist you and your family throughout your career journey.

Our success is rooted in the expertise, capabilities, and quality of our workforce.

That’s why we are dedicated to nurturing our employees within a culture of continuous learning – one that challenges you with meaningful work and where every experience contributes to your professional growth.


Pharmaceutical Research Associates, Inc is an equal opportunity and inclusive employer, committed to fostering a workplace free from discrimination and harassment.

All qualified candidates will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


If you require reasonable accommodation due to a medical condition or disability during any part of the application process, or to perform essential job functions, please inform us.


Interested in the position but uncertain if you meet all qualifications? We encourage you to apply regardless – you may be the ideal candidate we are seeking at Pharmaceutical Research Associates, Inc for this or other roles.

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