Want to know if this job is worth applying to?
София, София-град, България
Remote only
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking an experienced Senior/Principal Statistician Consultant to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development.
Key Responsibilities
Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials.
Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies.
Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation.
Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance.
Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams.
Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans.
Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges.
Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents.
Identify statistical risks and recommend appropriate solutions throughout the clinical development process.
Provide technical guidance and mentorship to statisticians and other team members, as appropriate.
Required Qualifications and Experience
PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies.
Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.
Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses.
Experience supporting clinical development programs in oncology, rare diseases, and/or neuroscience.
Experience supporting regulatory submissions and health authority interactions.
Experience with complex clinical trial designs and advanced statistical methodologies.
Proficiency in statistical programming tools such as SAS and/or R.
Strong analytical, problem-solving, communication, and stakeholder-management skills.
Ability to work independently and collaborate effectively with global cross-functional teams.
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
