Associate Director/Director Biostatistics

Structure Therapeutics•South San Francisco, CA

About The Position

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Position Summary: The position provides biostatistics support an exciting portfolio of Structure’s experimental drugs, with a primary focus on Phase 3 studies. Independently provides statistical input to drug development planning, including feasibility assessments, development plans, complex/innovative study designs, novel statistical methodology, interpretations, regulatory submissions (NDA, MAA and JNDA) and follow up. He/She is accountable to produce high quality biostatistics deliverables by performing the work themselves or providing oversight of the work performed by CROs.

Requirements

A PhD in Statistics/Biostatistics and at least 6-8 years of clinical development and analysis and reporting experience within the biotech/pharmaceutical industry depending on the positions qualifies.
Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, and Study Data Standardization Plan
Comprehensive knowledge of statistical methodology in design and analysis of clinical trials
Experience in implementing innovative study designs and novel statistical methodologies
Deep knowledge in clinical development including regulatory requirements in multiple regions
Excellent programming skills of SAS or R is strongly desirable
Excellent verbal and written communication skills and inter-personal skills

Nice To Haves

Tracking record of successive clinical trial designs/analysis in biotech/pharmaceutical industry setting and hands on statistical analysis experiences

Responsibilities

Provides biostatistics support to Structure’s expanding portfolios
Provide statistical support for clinical study design, endpoint selection, sample size calculations, randomization schedules, statistical analysis plans (SAP) and data interpretation in collaboration with all team members, including programmers, data manager, medical writers and clinicians.
Evaluate and implement innovative study designs and novel statistical methodologies as appropriate.
Act as the primary study contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors
Work closely with colleagues (Medical, Data Management, Statistical Programmers, Medical Writing, Safety, Clinical Operations, and Regulatory teams) to: Review protocols and prepare statistical methods section(s), including sample size estimation and clinical endpoint selection, to ensure Structure’s conducts well designed, efficient, and cost-effective as well as statistically valid clinical trials
Generate and/or review randomization schedule(s) to ensure high statistical quality of clinical protocols and analyses. Perform ongoing monitoring of actual randomization scheme applied by IVRS/IWRS
Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed
Prepares and/or reviews detailed Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of clinical study report
Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications.
Coordinate and lead team review and consolidation of comments for SAP and mock-TLFs.
Lead the study unblinding and validate TLFs post database lock
Lead and manage external (and/or internal) biostatistics resources supporting studies
Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
Independently complete submission of clinical data to various agencies (e.g., CDISC SDTM, ADaM, Define.xml, Reviewers Guide, via eCTD) and provide CRO oversight in ensuring deliverables meet project needs, standards, and compliance
Keeps abreast of literature/advancements in science/medicine/technology/statistics/standards in own and related fields of the drug development programs
Perform other duties and responsibilities as assigned.