Biostatistics – Gan & Lee Pharmaceuticals

Title of the Job: Biostatistics

Location: Bridgewater, NJ

Job Description: Summary
This position is responsible for providing statistical input to development strategies, and ensuring effective implementation, in order to support product development objectives within one or more therapeutic areas. This position is responsible for all biostatistical activities of Gan &Lee projects that are correctly designed, properly analyzed, and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. This individual reports to the head of Clinical Sciences.Education and Experience

• MS in Biostatistics/Statistics/Computer Science/Biology/Pharmacy or related field, PhD is preferred
• 3-10 years of experience in data management, preferably in clinical research or biotechnology.
• Proven experience leading teams and managing multiple projects simultaneously.

Skills and Qualifications

• Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
• Ability to provide technical solutions to a wide range of difficult problems.
• Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional.
• Proficient in SAS or R programming and certification in clinical data management (e.g., CDISC, SCDM) are preferred, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations.
• Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
• Able to manage multiple projects simultaneously, to manage and coordinates limited resources to produce quality deliverables within timelines for competing priorities, and to be flexible when priorities change.
• Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics.

Responsibilities

• Contributes to the development of study protocols, in particular, the statistical sections (e.g., sample size calculations, statistical methodology and analyses).
• Develops statistical analysis plans and file/report specifications; determine appropriate statistical methodology for data analysis; reviews study setup activities including but not limited to randomization, CRFs and data edits.
• Performs statistical analyses, interprets statistical results, and assists in clinical study reports including integrated summaries for submissions.
• Contributes to development of submissions to worldwide regulatory agencies and preparation of responses to statistical issues arising in regulatory activities or from external development partners.
• Maintains liaison with clinical research personnel in order to identify and provide the statistical support required by the development strategy under the direction of the clinical leader.
• Participate and representing the company in communicating with health authorities for biostatistical approach
• Develop and implement data management strategies for clinical trials and research studies.
• Provide leadership to the data management team, fostering collaboration and ensuring adherence to timelines and quality standards.
• Oversee the design, development, and validation of data collection tools (e.g., CRFs, eCRFs) and databases.
• Ensure compliance with regulatory standards (e.g., GCP, FDA, EMA) and best practices.
• Collaborate with cross-functional teams (e.g., biostatistics, clinical operations, IT) to support study objectives.
• Serve as the point of contact for data management-related inquiries and audits.
• Monitor data entry, cleaning, and validation processes to ensure accuracy and completeness.
• Establish and maintain SOPs for data management activities.
• Provide training to internal teams and external partners on biostats processes and requirements.

Summary
This position is responsible for providing statistical input to development strategies, and ensuring effective implementation, in order to support product development objectives within one or more therapeutic areas. This position is responsible for all biostatistical activities of Gan &Lee projects that are correctly designed, properly analyzed, and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. This individual reports to the head of Clinical Sciences.Education and Experience

• MS in Biostatistics/Statistics/Computer Science/Biology/Pharmacy or related field, PhD is preferred
• 3-10 years of experience in data management, preferably in clinical research or biotechnology.
• Proven experience leading teams and managing multiple projects simultaneously.

Skills and Qualifications

• Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
• Ability to provide technical solutions to a wide range of difficult problems.
• Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional.
• Proficient in SAS or R programming and certification in clinical data management (e.g., CDISC, SCDM) are preferred, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations.
• Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
• Able to manage multiple projects simultaneously, to manage and coordinates limited resources to produce quality deliverables within timelines for competing priorities, and to be flexible when priorities change.
• Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics.

Responsibilities

• Contributes to the development of study protocols, in particular, the statistical sections (e.g., sample size calculations, statistical methodology and analyses).
• Develops statistical analysis plans and file/report specifications; determine appropriate statistical methodology for data analysis; reviews study setup activities including but not limited to randomization, CRFs and data edits.
• Performs statistical analyses, interprets statistical results, and assists in clinical study reports including integrated summaries for submissions.
• Contributes to development of submissions to worldwide regulatory agencies and preparation of responses to statistical issues arising in regulatory activities or from external development partners.
• Maintains liaison with clinical research personnel in order to identify and provide the statistical support required by the development strategy under the direction of the clinical leader.
• Participate and representing the company in communicating with health authorities for biostatistical approach
• Develop and implement data management strategies for clinical trials and research studies.
• Provide leadership to the data management team, fostering collaboration and ensuring adherence to timelines and quality standards.
• Oversee the design, development, and validation of data collection tools (e.g., CRFs, eCRFs) and databases.
• Ensure compliance with regulatory standards (e.g., GCP, FDA, EMA) and best practices.
• Collaborate with cross-functional teams (e.g., biostatistics, clinical operations, IT) to support study objectives.
• Serve as the point of contact for data management-related inquiries and audits.
• Monitor data entry, cleaning, and validation processes to ensure accuracy and completeness.
• Establish and maintain SOPs for data management activities.
• Provide training to internal teams and external partners on biostats processes and requirements.

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Company Name: Gan & Lee Pharmaceuticals

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