About the Role
The Director/Senior Director, Biostatistics drives the design of creative, innovative and efficient clinical trials, including collaborating with the clinical team to identify endpoints and study populations study, and utilizing progressive design such as adaptive, platform and basket studies. They will develop trial designs that address study objectives that will support regulatory approval and patient access.The Director/Senior Director, Biostatistics will assist in the development and implementation of departmental scientific policies, operational guidelines. They will also contribute to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses. The Director/Senior Director, Biostatistics will provide guidance and management to contractors to ensure high quality and timely deliverables.
They will also manage resources, set priorities, and ensure consistency and adherence to standards therein. This role will provide statistical collaboration within TrialSpark R&D and investment team on evaluating in-house/in-licensing business development opportunities as well as clinical development projects.
What you'll be doing
- Independently lead, initiate, and oversee the statistical support for the development of compounds at TrialSpark
- Work with the clinical and regulatory team in developing the strategy for designing clinical trials and overall product approval plan
- Develop study designs that address study objectives that will support medical research, and regulatory approval and patient access.
- Collaborate with cross-functional teams on the development of FDA briefing books. Attend FDA meetings, as necessary.
- Propose and critically evaluate asset development plan for either BD opportunity or internal development project via scenario analyses, statistical trial simulation and meta-analyses of appropriate historical data, regulatory precedence, and disease specific guidance.
- Ensure project teams have high-quality statistical support for creation of clinical development plans (CDP), study protocols, and operational details. Facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program
- Develop and implement SOP development required for statistical deliverables (e.g. study randomization scheme, top line results, etc) and enhancing statistical process and technical expertise. Lead development of biostatistical processes focusing on efficiency and quality, while maintaining or exceeding industry best practices.
- Effectively engage as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process. Collaborate with data management, statistical programming to ensure data collection, programming specification are consistent with study objectives and planned analyses.
- Lead all aspects of statistical reporting and ensure compliance with data submission guidelines, including review and/or authoring of study documents, such as CRF, SAP, Top Line Results, CSR. Knowledge of data standards including SDTM, ADaM, eSub packages, etc.
- Management of external vendors, including consulting statisticians. Oversee CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
- Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.
What we're looking for
- Ph.D in Statistics or biostatistics with at least 10 years of experience in the biotechnology, pharmaceutical industry. Exceptional MS/MA candidates will also be considered.
- Deep understanding of statistical designs and methods for early and late development programs.
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice in both US and other geographic regions.
- Experience in applying quantitative decision making methods to support internal Go/No-Go decisions.
- Significant prior experience interaction with health authority agencies such as FDA and EMEA.
- Demonstrated track record of leading role as biostatistician in progressing assets from early development to marketing applications.
- Outstanding ability and skills to effectively represent Biometrics and Data Management in interaction with senior management or cross-functional teams.
- Excellent verbal and written communication, and presentation skills.
- SAS, S-Plus/R, Sample size calculation software (e.g., EaSt, PASS and Nquery)
- Expert R programming skills a major plus.
TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.
The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.
TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.