עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
מלאה
45,000-60,000 ₪
We are looking for a Director, Biostatics who will be responsible for the decision-making regarding any statistical effects and lead a department of biostatisticians.
This full-time position is located in Israel and reported to the Vice President, Biostatistics & Data Management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Oversee statistical leadership in the ongoing clinical studies and for the development of new studies
Serves as a cross-functional expert across projects and teams, in particular: overseeing protocol development in conjunction with clinical development and operation teams, development of the Statistical Analysis Plan, and reporting study results in the Clinical Study Reports (CSRs). In addition to providing input to IDE and regulatory submissions.
Led the departments biostatistics professional aspects, in alliance with the statistical programming and data management aspects.
Support interactions with global health authorities, as well as with partner contract research organizations.
Serves as the department SME for internal and external audits
Ensure quality and timeliness of statistical deliverables
Responsible for the attestations of data integrity of clinical trials and accuracy of all statistical analyses across all studies.
Accountable for the accuracy of statistical proposals that are part of materials for health authority meetings
Contributes to external engagement with consultants, advisory boards, and DMCB
Provide consultations to Business Development, Medical Affairs, clinical operation, QA, regulatory department, Health economics and outcomes research (HEOR), pre-clinical Research, and other department in the organization as needed.
Resource and support analytical activities that are included in plans for scientific publications with the publication and medical affairs teams.
Continues to resource the team with ongoing assessment of capability needs
Mentors and develops members of the department
Establishes best practices, identifies the need, and drives the creation of functional standard operating procedure
This full-time position is located in Israel and reported to the Vice President, Biostatistics & Data Management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Oversee statistical leadership in the ongoing clinical studies and for the development of new studies
Serves as a cross-functional expert across projects and teams, in particular: overseeing protocol development in conjunction with clinical development and operation teams, development of the Statistical Analysis Plan, and reporting study results in the Clinical Study Reports (CSRs). In addition to providing input to IDE and regulatory submissions.
Led the departments biostatistics professional aspects, in alliance with the statistical programming and data management aspects.
Support interactions with global health authorities, as well as with partner contract research organizations.
Serves as the department SME for internal and external audits
Ensure quality and timeliness of statistical deliverables
Responsible for the attestations of data integrity of clinical trials and accuracy of all statistical analyses across all studies.
Accountable for the accuracy of statistical proposals that are part of materials for health authority meetings
Contributes to external engagement with consultants, advisory boards, and DMCB
Provide consultations to Business Development, Medical Affairs, clinical operation, QA, regulatory department, Health economics and outcomes research (HEOR), pre-clinical Research, and other department in the organization as needed.
Resource and support analytical activities that are included in plans for scientific publications with the publication and medical affairs teams.
Continues to resource the team with ongoing assessment of capability needs
Mentors and develops members of the department
Establishes best practices, identifies the need, and drives the creation of functional standard operating procedure
Requirements:
Qualifications:
PhD or Masters degree in computational biology/ Biostatistics.
Knowledge:
At least 7 years experience in the medical device or pharmaceutical industry.
At least 5 years of managerial experience, including hiring and building a team.
Experience in analyzing randomized clinical trials using SAS including. superiority and non-inferiority analyses, CPHMs, sample size assessments, and clinical trial design.
Experience in writing the statistical sections of clinical trial reports.
Experience in writing statistical analysis plans.
Excellent written and spoken English.
Excellent computer skills using: SAS, Python, Office.
OTHERS:
Ability to travel abroad 10% of the time.
Qualifications:
PhD or Masters degree in computational biology/ Biostatistics.
Knowledge:
At least 7 years experience in the medical device or pharmaceutical industry.
At least 5 years of managerial experience, including hiring and building a team.
Experience in analyzing randomized clinical trials using SAS including. superiority and non-inferiority analyses, CPHMs, sample size assessments, and clinical trial design.
Experience in writing the statistical sections of clinical trial reports.
Experience in writing statistical analysis plans.
Excellent written and spoken English.
Excellent computer skills using: SAS, Python, Office.
OTHERS:
Ability to travel abroad 10% of the time.
This position is open to all candidates.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
