About this role.
ClinChoice is seeking a Senior/Principal Biostatistician Consultant to support infectious disease programs (Bronchiectasis or Hepatitis B). The role involves protocol development, statistical analysis plans, and ensuring data integrity. Ideal candidates have an MS/PhD in Statistics/Biostatistics, strong SAS/R skills, and clinical trial experience. This fully remote position offers the stability of a global CRO with direct sponsor engagement. Excellent communication and independent work capabilities are essential.
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Cover letter sample
I am excited to apply for the Senior/Principal Biostatistician Consultant position at ClinChoice. With a PhD in Biostatistics and over eight years of experience in clinical trials, I have led statistical analyses for infectious disease programs including Hepatitis B. My expertise in SAS and R ensures robust study designs and regulatory-compliant outputs.
I have a proven track record of developing statistical analysis plans, performing sample size calculations, and collaborating with cross-functional teams. In my previous role at a CRO, I successfully supported Bronchiectasis studies, delivering high-quality results on schedule.
I thrive in client-facing roles and am adept at building trust while working independently. I am eager to bring my technical skills and industry knowledge to ClinChoice to support your client’s programs.
Thank you for considering my application.
Sample interview questions
I have applied Poisson regression and negative binomial models in several infectious disease studies to analyze event rates, such as exacerbations in bronchiectasis. These methods account for overdispersion and varying follow-up times, and I have implemented them in SAS using PROC GENMOD and in R using glm.nb from the MASS package.
I conduct thorough data checks, including review of data listings, validation of derived datasets, and cross-checking outputs against analysis plans. I also implement QC processes like independent programming and traceability matrices to ensure tables, figures, and listings align with source data.
In a hepatitis B study, we encountered unexpected missing data due to patient dropouts. I proposed a sensitivity analysis plan using multiple imputation and pattern-mixture models to assess robustness. This was accepted by the client and regulatory team, ensuring valid conclusions.
I focus on clear, non-technical language and use visual aids like graphs and simplified summary tables. I regularly present at cross-functional team meetings and provide written summaries that highlight key findings and clinical relevance without jargon.
I have contributed to multiple NDAs and BLA submissions by preparing statistical sections, responding to regulatory queries, and presenting at advisory committee meetings. My work ensures compliance with ICH E9 guidelines and adherence to submission timelines.
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? Our team says it’s the best of both worlds….
ClinChoice is searching for a Senior /Principal Biostatistician Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
- Serve as study statistician or support statistician on Bronchiectasis or Hepatitis B programs
Primary Responsibilities:
- Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
- Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise.
- Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
- Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
- Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
Qualification:
- MS or PhD in Statistics, Biostatistics or related field.
- High degree of technical competence
- Understanding of Poisson regression or negative binomial methods, time to event, or multiple imputation methods
- Competent in experimental design, descriptive and inferential statistics.
- Pharmaceutical or related industry experience with clinical trials.
- Vaccines or infectious disease experience preferred but not essential
- Excellent communication skills, both oral and written.
- Excellent programming skills (SAS/R)
The Application Process
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
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: 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. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Contract
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