About TrialSpark

On a mission to bring new treatments to patients faster and more efficiently

Founded in 2016, TrialSpark is a tech-driven Pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data.

The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases.

About the Position

The Director of Biostatistics will report to VP, Biometrics and serve as a key leader to support the clinical development at TrialSpark. The Director of Biostatistics will lead all biostatistics activities for an important therapeutic area (TA). In addition, the Director of Biostatistics will collaborate with the technology team and lead the clinical trial simulation engine development at TrialSpark.

Responsibilities

• Lead, initiate, and oversee the statistical strategy and technical activities for the development of an important TA at TrialSpark.
• Contribute to the clinical development plans, regulatory strategy and commercial strategy for indications and projects of the assigned TA.
• Lead all statistical activities related to design, delivery and interpretation, internal governance committees, and regulatory submissions of the assigned TA projects.
• Develop study designs that address study objectives that will support medical research, and regulatory approval and patient access.
• Propose and critically evaluate development plan for assigned TA projects via scenario analyses, clinical trial simulation and meta-analyses of appropriate historical data, regulatory precedence, and disease specific guidance.
• Collaborate with cross-functional teams on the development of regulatory documents and attend regulatory meetings.
• 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, eCTD, 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.
• Collaborate with the technology team and lead the clinical trial simulation engine development at TrialSpark. The clinical trial simulation engine will be applied across TAs to provide quantitative assessments to enable the business to make informed decisions.

Requirements

• Ph.D in Statistics or biostatistics with at least 7 years of experience in the biotech or 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 ICH guidelines and regulatory requirements 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 EMA.
• Demonstrated track record of leading role as biostatistician in progressing assets from early development to marketing applications.
• Outstanding ability and skills to effectively represent Biostats in interaction with senior management or cross-functional teams.
• Extensive experiences in clinical trial simulations, applying frequentist and Bayesian framework in decision making and design evaluations in product development plans.
• Excellent verbal and written communication, and presentation skills.
• SAS, R/S-Plus, Sample size calculation software (e.g., EAST, PASS and nQuery).
• Expert R programming skills are a major plus.

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at TrialSpark. The target salary range for this role is $246,000 - $300,000.

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

If this range doesn’t match your expectations, please still apply because we may have something else for you.

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.