Manager/Sr. Manager, Statistical Programming

Eidos Remote - United States Biostatistics & Data Management

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About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

The Manager/Sr. Manager, Statistical Programming is a member of the Biostatistics team and is an individual contributor in charge of SAS programming production and validation activities. Responsibilities include CSR programming, review of standard study documents, and ensuring study and database integrity.

Responsibilities

 

  • Primary SAS production and validation programmer for Phase I and IV studies
  • Primary responsibilities included CSR programming, review of standard study documents, ensuring study and database integrity
  • Following programming standards and ensuring compliance with SOPs to produce high-quality and timely deliverables
  • Complete project deliverables on time and with utmost quality, assist other programmers in meeting study deadlines
  • Develop SAS programs to create SDTM/ADaM datasets and ensure they pass Pinnacle 21 checks
  • Ability to generate and review the TFLs, XPT files, define.xml, cSDRG, ADRG, and aCRF for submission to various regulatory agencies
  • Handle multiple project queries and/or ad-hoc requests efficiently and meet various project deadlines
  • Seek clarification with Study Statistician on planned study analysis and develop ADaM datasets and TFLs as per the study requirements
  • Collaborate with DM to review vendor DTS and check the vendor data transfers
  • Developed standard macros to avoid repetitive tasks and ensure uniformity in reporting

 

No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

 

  • MS (or equivalent degree) with 5+ years or BS with 7+ years of relevant work experience in clinical research as a SAS programmer for phase I-IV clinical trials in a Biotech, Pharma, Clinical Research Organizations, or other relevant organizations
  • Highly competent with SAS language and procedures commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH. Familiarity or experience with R Software is a plus
  • Well-organized with the ability to multitask and manage shifting priorities in a dynamic, cross-functional teamwork environment
  • Excellent collaboration skills with attention to detail and willingness to help other study programmers when the need arises
  • Demonstrated excellent analytical, technical, and computer skills
  • Excellent verbal and written communication skills are required

 

What We Offer

  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$140,000$200,000 USD

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Manager/Sr. Manager, Statistical Programming

Eidos Remote - United States Biostatistics & Data Management

Apply Now