Director / Senior Director, Biostatistics

At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.

Essential Functions:

In this leadership opportunity, you will be responsible for directing DICE Biostatistics and Data Science efforts, including input into clinical development planning, protocol development, study design, planned and ad hoc analyses, vendor oversight, SOP development, regulatory interactions and more. Your role will include ensuring consistency across the organization to enable accelerated drug development and accurate regulatory filings. You are expected to support the day-to-day statistical and data science needs of the company and provide CRO oversight on the statistical deliverables.  You will be responsible to assure adherence to GCP in conduct of DICE trials, with your primary objectives being the quality and integrity of generated data, and the rights and welfare of participants/patients.  Proven leadership and the ability to work in a fast-paced environment are essential for this position. This position reports to the Chief Medical Officer.

Key Responsibilities:

·       Provide statistical leadership in clinical development planning, protocol development, study design and statistical analysis

·       Direct and advise Vendor Management in the evaluation (RFI/RFP process), selection (including assessment of proposal responses, budget analysis) and performance of biometrics external partners to ensure compliance with DICE corporate strategy and in accordance with scope of work

·       Ensure statistical integrity of the deliverables generated by CRO vendors

·       Lead budget oversight activities related to biostatistics strategy; identifies opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced biostatistical services across the portfolio; and assist leadership with outside spend, budget planning and management of actual spend (invoices, PO) for biostatistics and data science

·       Lead the analysis and results preparation for investor meetings, regulatory meetings, national and international conferences, and contribute to the writing and review of manuscripts

·       Serve as DICE’s biostatistics and data science representative in regulatory (FDA, EMEA, etc.) meetings and support data evidence preparation.

·       Act as an advocate for proper experimental design and interpretation of statistical results across the company, and be able to credibly and effectively defend techniques used and conclusions drawn to external stakeholders

Preferred Experience and Education:

·       A Ph.D. in biostatistics or the equivalent with 8+ years of industry experience in pharma or biotech companies; or a Master's degree in biostatistics or the equivalent with 12+ years of industry experience

·       Minimum 4 years direct oversight of CRO vendors

·       Prior experience with immunology and dermatology trials is highly preferred

·       Can program in SAS and/or R

·       Prior experience supporting NDA/BLA submissions is preferred

·       Proven ability to manage multiple projects while maintaining quality is required

·       Proactive, energetic, self-assured professional with high personal integrity 

·       Demonstrated success in analyzing, interpreting and solving complex issues 

·       Ability to think strategically and objectively and with creativity and innovation

·       Exceptional verbal, written communication skills and presentation skills

·       Position is based in South San Francisco, with potential for flexible work arrangements  

DISCLAIMER

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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