Full-Time

Director – Biostatistics

Confirmed live in the last 24 hours

BridgeBio

BridgeBio

501-1,000 employees

Develops medicines for genetic diseases

Compensation Overview

$220k - $260kAnnually

+ Performance Bonus + Equity

Senior, Expert

Remote in USA

Candidates must be based in the United States.

Category
Computational Biology
Public Health
Biology & Biotech
Required Skills
SAS
R
Requirements
  • 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
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

BridgeBio Pharma develops medicines specifically for genetic diseases, focusing on conditions with well-understood genetic causes. The company uses a decentralized subsidiary model, allowing each subsidiary to concentrate on therapies for specific diseases while sharing central resources. This structure enhances efficiency and enables the advancement of multiple drug programs at once. BridgeBio utilizes advancements in genome sequencing and molecular biology to identify and develop effective treatments. Their goal is to create significant therapeutic improvements by targeting diseases at their genetic source. With over 15 drug programs aimed at 20 different genetic diseases, BridgeBio aims to reduce the time it takes to bring treatments to market through a diversified approach. The company promotes a culture of independent thinking and transparency, which supports quick, data-driven decision-making.

Company Size

501-1,000

Company Stage

IPO

Headquarters

Palo Alto, California

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • Increased focus on RNA-based therapies aligns with BridgeBio's genetic disease mission.
  • Decentralized clinical trials enhance data collection, benefiting BridgeBio's model.
  • Growing personalized medicine demand supports BridgeBio's targeted genetic therapies.

What critics are saying

  • Alnylam's RNAi therapy Amvuttra poses competition to BridgeBio's ATTR-CM treatment.
  • Strategic shifts from new leadership may impact genetic disease program focus.
  • Norges Bank's investment may pressure BridgeBio for short-term financial performance.

What makes BridgeBio unique

  • BridgeBio employs a decentralized subsidiary model for efficient drug development.
  • Focuses on genetic diseases with well-understood underlying causes for targeted therapies.
  • Leverages genome sequencing and molecular biology for innovative treatment solutions.

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Benefits

Health Insurance

Performance Bonus

Company Equity

Unlimited Paid Time Off

Growth & Insights and Company News

Headcount

6 month growth

5%

1 year growth

3%

2 year growth

2%
GlobeNewswire
Feb 26th, 2025
BridgeBio Prices Offering of $500 Million Convertible Senior Notes due 2031 to Refinance Senior Secured Debt

Refinancing term debt facility lowers interest expense, eliminates near-term amortization payments, and significantly extends debt maturityOffering priced...

The Manila Times
Jan 8th, 2025
BridgeBio Pharma to Participate in the J.P. Morgan Healthcare Conference

PALO ALTO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) - BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced that co-founder and CEO, Neil Kumar, Ph.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 13 at 7:30 am PT.

Access Market Intelligence
Dec 6th, 2024
Orsini and PANTHERx Rare Selected by BridgeBio as Pharmacy Partners for ATTRUBY

PANTHERx Rare, a leader in rare disease product patient access and support services in the United States, also announced that it was selected by BridgeBio for the distribution of Attruby (acoramidis).

PR Newswire
Nov 26th, 2024
Bridgebio Selects Pantherx® Rare Specialty Pharmacy For Distribution Of Attruby™ (Acoramidis)

PITTSBURGH, Nov. 26, 2024 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by BridgeBio for the distribution of Attruby™ (acoramidis), a high-affinity transthyretin (TTR) stabilizer for twice daily oral administration, approved for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).2,5. Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby was designed to mimic a naturally occurring "rescue mutation" of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer. Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes. "Panther is committed to providing tailored solutions for people living with rare and devastating conditions and we look forward to the partnership with BridgeBio and serving the needs of patients suffering from transthyretin amyloid cardiomyopathy," said Rob Snyder, Executive Chair, PANTHERx® Rare Pharmacy

MarketBeat
Nov 24th, 2024
Jennison Associates LLC Invests $767,000 in BridgeBio Pharma, Inc. (NASDAQ:BBIO)

Jennison Associates LLC invests $767,000 in BridgeBio Pharma, Inc. (NASDAQ:BBIO).