Sr. Director/Executive Director, Head of Biostatistics

COMPANY INTRODUCTION

Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine.  We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.

SUMMARY 

The Senior/Executive Director, Head of Biostatistics will be responsible for leading the biostatistics function within the company.  Reporting to the Chief Development Officer, this role will be critical in developing the strategy, systems, and processes necessary to support clinical development programs, regulatory submissions, and overall data-driven decision-making. The ideal candidate will have deep expertise in biostatistics, programming, and real-world evidence, coupled with strong leadership skills and experience operating in a fast-paced biotech environment.

RESPONSIBILITIES 

•Provide strategic input into the design and execution of clinical trials, ensuring robust statistical methodologies are applied.

•Lead the planning and execution of statistical analyses, ensuring accurate and timely delivery of high-quality data for clinical trials and regulatory submissions.

•Lead the statistical aspects of regulatory submissions, including the preparation of statistical analysis plans (SAPs), clinical study reports (CSRs), and responses to regulatory inquiries.

•Procure and manage necessary resources for programming, data visualization, and data analysis, ensuring integration across all clinical programs.

•Ensure all biostatistical activities comply with global regulatory requirements, including FDA, EMA, and other international health authorities.

•Oversee the development, implementation, and maintenance of biometrics processes and systems, ensuring data integrity and compliance with regulatory standards.

•Collaborate closely with Data Sciences on the analysis of registries and databases that provide real-world evidence supporting clinical programs and indication expansion.

•Provide expert statistical consultation and guidance to internal stakeholders, supporting data-driven decision-making across the organization.

•Stay abreast of emerging trends and innovations in biostatistics, data management, artificial intelligence (AI) and statistical programming, incorporating best practices into the biometrics function.

Lead the development and implementation of new statistical methodologies and technologies to enhance the efficiency and effectiveness of clinical trial design and analysis.

•Identify and manage risks related to statistical design and data quality, implementing strategies to mitigate potential issues.

•Other duties as assigned.

EXPERIENCE & QUALIFICATIONS

•Advanced degree in biostatistics, statistics, mathematics, or a related field (PhD strongly preferred).

•12 years of experience in biostatistics and biometrics within the biopharmaceutical industry.

•Extensive experience with global regulatory requirements and submissions, including FDA and EMA guidelines.

•Proven track record of leading a biostatistics function in a fast-paced environment.

•Superior communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders, including regulatory authorities.

•Proficiency in statistical software (e.g., SAS, R) and data management tools.

Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.