Director, Biostatistics Job Summary: We are seeking an experienced Director of Biostatistics to provide scientific and technical leadership for our clinical development programs.In this role, you will lead all biostatistical activities and serve as a biostatistical expert across allassigned projects, ensuring the highest standards of scientific rigor and regulatory compliance.
Key Responsibilities: • Provide statistical leadership and support across all clinical development functions and lead all assigned projects within the Biometrics department. • Participate and interact with clinical and cross-functional teams in the development of protocols, study design, and endpoints discussions. • Develop and review statistical sections of protocols, SAPs, study reports, and regulatory documents. • Apply advanced statistical methodologies, such as survival analysis, Bayesian analysis, handling missing data and adaptive designs. • Provide statistical support to Clinical Operations, Regulatory Affairs, Medical Affairs, Translational science, and RWE functions. • Support regulatory submissions work and generation of ISS/Client. • Ensure consistency within Biometrics functions, including Programming and Data Management, for all deliverables to enhance efficiency and quality. • Represent Biostatistics in meetings with regulatory authorities. • Develop and implement departmental SOPs for statistical activities in accordance with ICH, GCP, guidelines, and CDISC standards (SDTM/ADaM). • Manage and oversee the work of CROs and other external vendors to ensure the quality and timeliness of deliverables.
Qualifications, Experience, & Competencies: • A master's or PhD degree in biostatistics or a related field is required. • At least 10 years of experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry is essential. • Proficiency in SAS and/or R.Familiarity with CDISC standards (SDTM, ADaM) is essential.Page 2 of 2 • In-depth experience and expertise in applying biostatistical methodologies to clinical development are highly desirable. • Understanding of FDA, EMA and ICH regulations and guidelines.
Experience working on regulatory submissions is preferred. • Excellent verbal and written communication skills are essential, along with the ability to work effectively as part of a team. • Must be able to work independently with minimal supervision. • Additionally, the ability to travel up to 5% of the time, depending on the business's needs, is required.
Director, Biostatistics Job Summary: We are seeking an experienced Director of Biostatistics to provide scientific and technical leadership for our clinical development programs.In this role, you will lead all biostatistical activities and serve as a biostatistical expert across allassigned projects, ensuring the highest standards of scientific rigor and regulatory compliance.
Key Responsibilities: • Provide statistical leadership and support across all clinical development functions and lead all assigned projects within the Biometrics department. • Participate and interact with clinical and cross-functional teams in the development of protocols, study design, and endpoints discussions. • Develop and review statistical sections of protocols, SAPs, study reports, and regulatory documents. • Apply advanced statistical methodologies, such as survival analysis, Bayesian analysis, handling missing data and adaptive designs. • Provide statistical support to Clinical Operations, Regulatory Affairs, Medical Affairs, Translational science, and RWE functions. • Support regulatory submissions work and generation of ISS/Client. • Ensure consistency within Biometrics functions, including Programming and Data Management, for all deliverables to enhance efficiency and quality. • Represent Biostatistics in meetings with regulatory authorities. • Develop and implement departmental SOPs for statistical activities in accordance with ICH, GCP, guidelines, and CDISC standards (SDTM/ADaM). • Manage and oversee the work of CROs and other external vendors to ensure the quality and timeliness of deliverables.
Qualifications, Experience, & Competencies: • A master's or PhD degree in biostatistics or a related field is required. • At least 10 years of experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry is essential. • Proficiency in SAS and/or R.Familiarity with CDISC standards (SDTM, ADaM) is essential.Page 2 of 2 • In-depth experience and expertise in applying biostatistical methodologies to clinical development are highly desirable. • Understanding of FDA, EMA and ICH regulations and guidelines.
Experience working on regulatory submissions is preferred. • Excellent verbal and written communication skills are essential, along with the ability to work effectively as part of a team. • Must be able to work independently with minimal supervision. • Additionally, the ability to travel up to 5% of the time, depending on the business's needs, is required.
