Sr. Director, Biostatistics

Biostatistics Role At Structure Therapeutics

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.

Position Summary:

The position provides biostatistics support to an exciting portfolio of Structure's experimental drugs, including overseeing multiple programs. This role is responsible to provide strategic statistical input to drug development planning, including feasibility assessments, development plans, complex/innovative study designs, novel statistical methodology, analyses, interpretations, regulatory submissions (NDA, MAA and JNDA) and post-approval activities. This role will partner cross-functionally with Stat Programming, Data Management, Clinical Development, Regulatory, and external vendors to ensure high-quality, timely delivery of statistical outputs. He/She is accountable for the production of biostatistics deliverables by providing oversight of the work performed by internal statistical programming team, or performing the work themselves. This position may have direct supervisory responsibilities for internal staff or external consultants.

Job Responsibilities:

• Provides biostatistics support to Structure's expanding portfolios
• Work closely with colleagues (Medical, Statistical Programmers, Data Management, Medical Writing, Safety, Clinical Operations, and Regulatory teams) to:
• Review protocols and prepare statistical methods section, including endpoint selection, sample size calculations, estimand definition, handling of intercurrent events, and Type I error control, to ensure Structure's studies are well designed, cost-effective and statistically valid
• Generate and/or review randomization schema(s) to ensure high statistical quality of clinical analyses
• Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed
• Prepares detailed Statistical Analysis Plan (SAP) and develop standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of outputs generated by programmers) for milestone readouts
• Create or review programming specifications for analysis datasets and TLFs, including SDTM, ADaM and TFL programming specifications
• Coordinate and lead team review and consolidation of comments for SAPs, mock-TLFs, and draft TLFs
• Lead the study unblinding and validate TLFs post database lock
• Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions
• Review study reports, manuscripts, and regulatory submission documents to ensure accurate and statistically valid interpretation of the study outcomes
• Responsible for providing statistical leadership for preparation of marketing applications to FDA, EMA, or other worldwide regulatory agencies
• Ensure consistency and alignment of statistical approaches across studies within a program
• Develop Standard Operating Procedures, work instructions, guidelines, data standards, and processes as needed to govern the biostatistics group and deliverables
• Keeps abreast of literature/advancements in science/medicine/technology/statistics/standards in own and related fields of the drug development programs, including AI technologies

Qualifications:

• A PhD or Master in Statistics/Biostatistics
• 12+ years of clinical development and analysis and reporting experience within the biotech/pharmaceutical industry depending on the positions qualify.
• Comprehensive knowledge of statistical methodology in design and analysis of clinical trials. Experience in implementing innovative study designs and novel statistical methodologies
• Proven competencies in interaction with health Authorities (FDA, EMA and PMDA) and eCTD (NDA/BLA) submissions preferred.
• Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, and Study Data Standardization Plan
• Experience in leading development and optimization of Biometrics processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices
• 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

Preferred Experience:

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

Travel:

• 5 - 10% travel required
• Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences.

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $261,000-$315,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.