Clinchoice Inc.

Principal Biostatistician Consultant- Remote in US (Oncology)

United States · Principal

Sponsorship not specifiedDetected 26 days ago

Computer VisionStatisticsClinical TrialsFDA RegulatoryMedical DevicesSASExperimental DesignLeadershipCommunicationBiostatistics

About the role

We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs.

Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
Design and review statistical methodologies for efficacy and safety analyses.
Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.
Provide strategic input on study design, endpoint selection, and sample size calculations.
This role will support Phase I-III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.

8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.
Strong experience in oncology clinical trials.
Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.
Proficiency in SAS and/or R.
Strong knowledge of CDISC standards (SDTM, ADaM).
Experience supporting regulatory submissions.
PhD or MS in Statistics, Biostatistics, or related field.
Excellent communication and leadership skills.

Experience with adaptive designs and Bayesian methods.
Prior experience interacting with regulatory agencies.
Experience in immuno-oncology or hematology oncology.
Once you have submitted your CV, you will receive an acknowledgement that we received it.
If you have the requirements we need, you will be invited for phone interview as the first step.
Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice

Collaborate with clinical development, data management, programming, regulatory, and medical teams.
Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).

to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer.
We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring

This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.