Be an early applicantLess than 25 applicants

Company

BridgeBio · 9 hours ago

Associate Director, Biostatistics

Remote - United States

Full-time

Remote

Senior Level, Lead/Staff

$185K/yr - $235K/yr

8+ years exp

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BiotechnologyHealth Care

Growth Opportunities

H1B Sponsor Likely

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Responsibilities

Provide statistical input to study design, protocol development, sample size calculation, Case Report Form, Results Interpretation, clinical study report, and addressing questions from regulatory agencies. Collaborating with CRO, develop and maintain SAPs, including the derived variables, the templates of statistical tables, figures, and listings, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications

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

Works collaboratively with Statistical Programmers, Biostatisticians, 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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

. in StatisticsBiostatistics expertiseSAS programmingR programmingCDISC standards knowledgeICH guidelines familiarityFDA regulatory guidanceNDA experience

Required

Ph. D. in statistics or biostatistics and 5+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry

Proven knowledge and expertise in statistics and its applications to clinical trials

Team player with the ability to work successfully across functions

Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms

Demonstrated leadership skills

Proficiency with statistical programming in SAS and/or R

Knowledgeable in CDISC standards, including SDTM, ADaM

Familiar with ICH guidelines, FDA, and other regulatory authority guidance

Preferred

Preferably NDA experience, including eCTD submission

Benefits

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

Flexible PTO

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

Rapid career advancement for strong performers

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)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (2)

2022 (3)

2021 (1)

2020 (3)