Job Summary:

The Director of Biometrics will lead the development and integration of a Biometrics group to support a growing clinical development organization. This role involves developing and overseeing operations and management of the functional areas of biostatistics, statistical programing and data management. The director will also work with senior management to develop and implement programs and processes to support corporate objectives and strategy.

Key Responsibilities:

• Responsible for statistical support of clinical and pre-clinical projects, including input into experimental design, sample size estimation, subject randomization, data management, statistical analyses and presentation of data.
• Ensure that systems and resources are in place to optimize the design, conduct, analysis and interpretation of clinical and non-clinical data.
• Plan, and directly oversee statistical, programming, and data management activities related to clinical programs either internally or through active and effective management of outside contractors and/or CRO’s.
• Provide consultation to clinical and regulatory functions regarding the conduct of studies, data management, statistical methodology, data analysis and interpretation and for planning and executing regulatory submissions.
• Provide biostatistics responses to statistical aspects of regulatory interactions. Ensure that all work performed meets appropriate regulatory requirements.
• Write and/or review statistics sections of regulatory documents (study protocols, study associated statistical analysis plans and regulatory submissions) and statistics sections of reports and publications.
• Responsible for case report design and review for studies.
• Review and approves study database specifications, data management plans, data transfer plans, CDISC and ADaM specifications, and ensure reviews as needed by other key stakeholders.
• Interface between internal study teams and external data management, statistical, and programming vendors to ensure appropriate communications and vendor relationships.
• Evaluate and select vendors, consultants and contractors responsible for providing data management, statistical support and statistical programming services to the company. Negotiate the scope of work and cost of services and ensure that projects are completed with quality and within the allotted budgets and timelines.
• Ensure adherence to quality control procedures for data management and statistical programming activities.
• Write appropriate Standard Operating Procedures (SOPs)/training guidelines for data management, statistical, and statistical programming activities.
• Work with project management to establish and ensure statistical, programming, and data management project deliverables meet expected timelines.
  
  

Required Qualifications:

• PhD in biostatistics, statistics or other relevant scientific discipline and a minimum of 8 years’ related experience in the pharmaceutical industry at either a contract research organization or pharmaceutical/biotech company or an equivalent combination of education and experience.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment
• Knowledge of FDA, EMA and ICH regulatory guidelines, clinical development processes, clinical trial design, statistical programming, data analysis and data management
• Experience with regulatory agency (FDA and EMA) interactions
• Knowledge of SAS and other statistical programming packages
• Able to think and act strategically
• Strong oral, written and listening skills
• Demonstrated high level of integrity and ethics
• Proficiency with MS Office
  
  

About Iambic Therapeutics

Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.

MISSION & CORE VALUES

The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

ALSO

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and unlimited vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.