62 applicants

Company

BridgeBio · 1 day ago

Director, Biostatistics

United States

Full-time

Remote

Director/Executive

$220K/yr - $260K/yr

11+ years exp

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BiotechnologyHealth Care

Growth Opportunities

H1B Sponsor Likely

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Responsibilities

Leads statistical and statistical programming team at the product level

Provides statistical input to strategic planning, study design, protocol development, sample size calculation, Case Report Form, Results Interpretation, clinical study report, and addressing questions from regulatory agencies. Develop and maintain SAPs, including the derived variables, the templates of statistical tables, figures, and listings

Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high-quality data

Works collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines

CRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide CRO biostatisticians and statistical programmers. Ensures deliverables are accurate and delivered according to the timelines

Global Health Authority Interaction: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities

Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities; attend team meetings

Qualification

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StatisticsStatistical methodologiesSAS programmingR programmingNDA submission experienceDrug development trendsRegulatory environments

Required

PhD in statistics or biostatistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 11+ years relevant experience in the pharmaceutical/biotechnology industry

NDA submission experiences

Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.

Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions

Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process

Excellent programming skills in SAS and/or R

Excellent oral and written communication skills

Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors

Benefits

Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)

Flexible PTO

Rapid career advancement for strong performers

Access to learning and development resources to help you get in the best professional shape of your life

Commitment to Diversity, Equity & Inclusion

Company

BridgeBio

BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.

Founded in 2015

Palo Alto, California, USA

201-500 employees

http://bridgebio.com

H1B Sponsorship

BridgeBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (2)

2022 (3)

2021 (1)

2020 (3)