Senior Director, Biostatistics
The Senior Director, Biostatistics is accountable for all or parts of Global Blood Therapeutics, Inc. (GBT) Biostatistics deliverables, including study design, data analysis, interpretation and reporting of results, publication, and regulatory submission, in collaboration with partner functions in Development and Medical Affairs. Provides statistical expertise and general program input into GBT drug development plans and global regulatory interactions. Collaborates with counterparts in Clinical Data Management, Statistical and Clinical Programming in providing Biometrics leadership and support for all phases of clinical development activities including medical communication and regulatory submissions. Attends health authority meetings as a member of the sponsor team as needed. Represents GBT Biometrics in one or more programs on industry, academia and health authority collaboration projects to enhance disease education and/or regulatory innovation in therapeutics development for sickle cell disease as appropriate. Leads Biostatistics organizational strategy and manages internal and CRO resources as needed. Leads or contributes to Biostatistics SOP development and maintenance, and other department initiatives. The successful candidate will be a strategic leader and a hands-on contributor with a proven track record of supporting complex drug development programs. Essential Duties and
Responsibilities:
Lead one or more GBT clinical stage compounds in providing statistical expertise and support to Development and Medical Affair clinical programs, publications, and regulatory submissions as needed Represent Biostatistics on clinical development team and/or study teams as needed; assure statistical integrity, adequacy and accuracy of statistical analysis and result interpretation Oversees development of statistical sections of protocol, SAP, and CSR Provide input in the selection of CROs, manage CRO activities for clinical studies in collaboration with internal partner functions to ensure timely delivery of project commitments with quality Cultivate collaborative working relationships with functional partners, including external contract or advisory organizations, and thought leaders Lead or contribute to the development of complex, technical solutions for projects or business needs Lead or contribute to the development and maintenance of SOPs and WIs for Biostatistics and provide input for other Biometrics SOP within Programming and Data Management Lead or contribute to industry/academia/health authority collaborations in SCD disease education, or regulatory innovation on behalf of GBT Biometrics Lead Biostatistics resource planning and manage direct reports as needed Contribute and engage with strategic decision making within Biometrics Manage junior statisticians and guide statistical programming efforts on key statistical analyses Contribute in developing ADaM standards, specifications and datasets Contribute to setting standards within Biometrics Adheres to and enforces the latest regulatory guidelines
Qualifications:
PhD in Statistics or Biostatistics with at least 14
years of pharma / biotech industry experience, or MS in Statistics or Biostatistics with at least 18 years of industry experience, and 5
years of team leadership or management experience Expert knowledge in the principles and techniques of clinical study design, data analysis and interpretation, and data-driven decision making. Familiarity with rare disease therapeutic areas is a plus Comprehensive understanding of regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission required Proficiency in SAS required, and knowledge of other languages (e.g. R) is a plus Proficient in understanding CDISC standards Excellent team leadership, verbal and written communication skills Strong critical thinking, problem solving and project management skills Team-builder who models entrepreneur spirit and fosters cross-functional collaborations Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Lead one or more GBT clinical stage compounds in providing statistical expertise and support to Development and Medical Affair clinical programs, publications, and regulatory submissions as needed Represent Biostatistics on clinical development team and/or study teams as needed; assure statistical integrity, adequacy and accuracy of statistical analysis and result interpretation Oversees development of statistical sections of protocol, SAP, and CSR Provide input in the selection of CROs, manage CRO activities for clinical studies in collaboration with internal partner functions to ensure timely delivery of project commitments with quality Cultivate collaborative working relationships with functional partners, including external contract or advisory organizations, and thought leaders Lead or contribute to the development of complex, technical solutions for projects or business needs Lead or contribute to the development and maintenance of SOPs and WIs for Biostatistics and provide input for other Biometrics SOP within Programming and Data Management Lead or contribute to industry/academia/health authority collaborations in SCD disease education, or regulatory innovation on behalf of GBT Biometrics Lead Biostatistics resource planning and manage direct reports as needed Contribute and engage with strategic decision making within Biometrics Manage junior statisticians and guide statistical programming efforts on key statistical analyses Contribute in developing ADaM standards, specifications and datasets Contribute to setting standards within Biometrics Adheres to and enforces the latest regulatory guidelines
Qualifications:
PhD in Statistics or Biostatistics with at least 14
years of pharma / biotech industry experience, or MS in Statistics or Biostatistics with at least 18 years of industry experience, and 5
years of team leadership or management experience Expert knowledge in the principles and techniques of clinical study design, data analysis and interpretation, and data-driven decision making. Familiarity with rare disease therapeutic areas is a plus Comprehensive understanding of regulatory guidelines for drug development. Experience in NDA/BLA/MAA submission required Proficiency in SAS required, and knowledge of other languages (e.g. R) is a plus Proficient in understanding CDISC standards Excellent team leadership, verbal and written communication skills Strong critical thinking, problem solving and project management skills Team-builder who models entrepreneur spirit and fosters cross-functional collaborations Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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