职位描述
临床数据分析
统计

The Position

Reporting to the CMO, the Head of Biometrics
will build and oversee an organization with leadership and accountability for
all biostatistics and statistical programming functions. He/she will play a key
role in designing protocols, interacting with Health Authorities, as well as
our partner contract research organizations (CRO).

He/she will also provide biometrics
consultations to cross-functional teams as needed and will be responsible for
recruiting, resourcing, and building infrastructure for Biometrics to support
Bolt’s clinical research portfolio.

Key Responsibilities
• Ensure overall
effective operations in biostatistics and clinical/statistical programming

• Oversee and lead
direct reports and Biometrics input in clinical development plans, clinical
translational protocols, regulatory documents, publications, internal and
external meetings, and presentations

• Accountability for
development, implementation and execution of statistical analysis plans that
support clinical development plans and clinical protocols; assures statistical
integrity, compliance, and accuracy

• Partnership with the
Clinical Operations Team for the consistency and accuracy of statistical
programming deliverables; including derived data definition, analysis file
structure, analysis methodologies, and analysis results

• Continue to build and
resource the Biometrics team; mentor and develop members of the Biometrics
organization

• Establish best
practices, identify the need, and drive the creation of functional standard
operating procedures for biostatistics statistical programming





Job Requirements

• Ph.D. （or master）in Biostatistics,
Statistics, and/or Programming

• Broad and extensive
knowledge of theoretical and applied statistics

• Demonstrated
understanding of Phase I - Phase IV drug development

• Comprehensive
understanding of regulatory guidelines for drug development

• Expert in the
principles and techniques of data analysis, interpretation, and clinical
relevance

• Expert level of
proficiency with SAS and/or other statistical software packages

• Proven track record of
fostering creativity, productivity, execution with a sense of urgency,
teamwork, accountability, and cross-functional collaboration

• Entrepreneurial,
self-starter with strong interpersonal and analytical skills; high ethical
standards; and proven ability to work effectively with cross-functional
partners and other internal stakeholders

• Excellent external
networking, relationship and presentation skills, and a strong presence

• Must have operational
leadership experience and management of direct reports

• Oncology experience
strongly preferred