Services

Alpha Kappa Statistics LLC provides you with the biostatistical guidance you need to help you from the beginning of the clinical development lifecycle through to approval and marketing.

Offerings:

Statistician for clinical trials (e.g., line level, individual contributor role)
  • Protocol Development including sample size estimation using nQuery software
  • Statistical Analysis Plan preparation
  • Preparation of Table shells
  • Programming of the Statistical Analyses (using SAS Software)
  • Writing the results of the statisical analyses for the CSR
  • Presenting the results to management

Technical and Strategic (e.g., Leadership role)
  • Prepare of clinical development plans
  • Design clinical trials with an eye on optimal design to expose the fewest subjects necessary to gain regulatory approval
  • Develop and review protocols using the most appropriate statistical methodology
  • Prepare and review clinical study reports for regulatory submission
  • Support the Medical Affairs mission: prepare and review manuscripts, abstracts, and posters
  • Prepare for and participate in meetings with regulatory authorities (experience in most therapeutic areas and with most divisions at the FDA)
  • Serve on Data Monitoring Committees:  DMC Statistician/Independent Statistician and Adjudication Committees for clinical trials
  • Write statistically accurate press releases
  • Prepare for due diligence investigations (experienced in licensing and selling)
  • Identify and recruiting talent
  • Consult to support organizational change
  • Provide a bridge between the leader who left and helping identify the next leader of Biostatistics
  • ​Representation and preparation for FDA Ad Comm meeting

My Clients Come First

I am available to you 24/7 to ensure that you rest assured that you are getting the statistical support you need, with quality and timeliness.

I have had the privilege to work with Jeff at 2 companies. His comprehensive grasp of biostatistics is second to none. His leadership and managerial abilities are outstanding. And he always conducts himself as a gentleman. I have always enjoyed interacting with Jeff, and I have learned quite a bit about biostatistics because of my interactions with him. If I needed a biostatistics expert, Jeff would be my pick."

Jeffrey Freid, MD
Vice President of Pharmacovigilance & Risk Management
​Endo Pharmaceuticals
December 12, 2018





"Jeff worked with me as a Statistical consultant during an extremely busy time. He joined at short notice and quickly got to grips with the projects and work at hand. He remained calm, was flexible at picking up a variety of tasks and brought his tremendous knowledge and experience to support the team in whatever way he could. He was a pleasure to work with."

June 7, 2022

Adrienne Motion, Formerly VP of Biometrics 
Aglea Pharmaceuticals.
​Retired in 2022

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