2027 Hiring Opportunities – Senior/Principal Statistician Consultant (Remote in
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- Posted yesterday · via Himalayas
Full Description
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. 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, biotechnol
Why This Role?
ClinChoice menawarkan kesempatan untuk berkembang profesional di lingkungan yang berkualitas dan berorientasi tim.
Key Responsibilities
- Beri kepemimpinan statistik di program pengembangan klinis dari fase awal hingga fase akhir
- Rancang uji klinis termasuk memilih endpoint, menghitung ukuran sampel, analisis daya, dan strategi randomisasi
- Membuat dan meninjau protokol studi klinis, rencana analisis statistik, dan dokumentasi statistik lainnya
- Mengawasi analisis statistik dan interpretasi data uji klinis untuk memastikan ketepatan ilmiah dan keteraturan regulasi
- Bekerja sama dengan tim pengembangan klinis, operasi klinis, manajemen data, urusan regulasi, dan penulisan medis
Requirements
- Memiliki gelar PhD dalam Statistik, Biostatistik, atau disiplin kuantitatif terkait
- Pengalaman signifikan dalam biostatistik
- Kemampuan untuk memberikan kepemimpinan statistik dan mentoring kepada tim
Required Skills
Indonesia Context
- Working Hours Overlap:
- Flexible — work your own hours
View Original Description from HimalayasShow more
Original description from Himalayas
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. 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, biotechnol
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