Associate Director, Biostatistics

Location
Redwood City, CA
Posted
May 06, 2022
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.

The Position
Reporting to the Head of Biometrics, the Associate Director of Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.

Key Responsibilities
• Independently leads the development and execution of statistical aspects for complex early clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications
• Participates in establishing and maintaining policies, standards, and procedures for biostatistics activities
• Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports and scientific publications, generates or reviews study randomization, sample size/power estimations
• Review of data validation checks to ensure analysis variable cleaning expectations are included.
• Review of TLF Shells and TLFs
• Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for that data will be included in SDTM
• Be able to code in SAS/R as needed
• Creation of a Study Data Standardization plan by program/ indication
• Ad hoc review of displays in support of publications/ board meeting, etc.
• Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions
• Performs and reports study results of statistical analyses to provide interpretation of data and sound study conclusions

Job Requirements
• Ph.D. degree in statistics and 4 years of relevant industry experience (or master's degree in relevant statistics field and 6 years of clinical trial experience) in the pharmaceutical or biotech companies, or related experience or equivalent combination of training and experience
• Proven knowledge and expertise in statistics and its applications to clinical trials.
• Oncology experience preferred
• Team player, with ability to work successfully across functions
• Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms
• Familiar with ICH guidelines, FDA, and other regulatory authority guidance
• Preferably NDA experience, including eCTD submission
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.