Principal, Statistical Programming ~ SAS

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 cancer.

The Position:

Reporting directly to the head of Biometrics the candidate will serve as the primary lead on Planning and coordinating the development of integrated programming solutions, serving the full spectrum of statistical programming needs.

Key Responsibilities:

· Provides comprehensive programming leadership and builds processes/SOPs to ensure a regulatory compliant environment.

· Responsible for management of CROs and contractors supporting the programming tasks for the clinical programs.

· Provides technical guidance to CROs around project conventions, standards, practices,and specifications to ensure integrated computing solutions.

· Drivesthedevelopmentandimplementationofinnovativestrategiesandtechnologiesforclinical trials programming.

· Collaborates with team members to review documents(e.g.,statistical analysis plans, CRFs, data transfer plans, data presentation plans, datareview plans) to ensure compliance with CDISC standards and clarity for specifications and statistical outputs.

· Ensures timely and quality delivery of all tasks by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.

· Develops unambiguous and robust programming specifications for internal and external programming workflow.

· Independently develops, troubleshoots, and maintain statistical programs.

Job Requirements:

· Programming experience with data from oncology clinical trials

· In-depth knowledge of CDISC standards as applicable to programming of SDTM/ADaM datasets and submission documents ( Define.xml, sDRG, aDRG)

· Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience

· Minimum of 10 years of clinical/statistical programming experience within pharmaceutical clinical development with experience that includes leading programming efforts to support regulatory filings (US, EU, Japan)

· Minimum 5 years of experience in managing technical professionals in a regulated environment

· Extensive knowledge of SAS software (i.e.Base , Stat, Graph components) and general computing techniques in addition to knowledge of R or other statistical software packages

· Significant knowledge of the drug development process, clinical trial methodology, statistics, and relevant regulatory requirements for drug approval

· Demonstrated ability to operate and lead in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.

· Able to adapt quickly to the changing needs of the organization.

· Able to organize multiple work assignments and establish priorities.

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.

Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Bolt will consider requests for Reasonable Accommodations.

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.