Associate Director, Biostatistics

Location
Palo Alto, CA, United States
Posted
Nov 25, 2020
Ref
257778593
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical 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 product candidate, 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company's focus on scientific excellence and rapid execution aim to translate today's discoveries into tomorrow's medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at eidostx.com/ www.bridgebio.com

Location:

San Francisco, CA

Who you are:

The Associate Director/Director of Biostatistics will lead statistical aspect of study design, analysis and data interpretation. The successful candidate will be a member of cross-functional team and will contribute to protocols, statistical analysis plans (SAPs), and documents submitted to Health Authorities globally. The successful candidate will also interact with internal and external cross-functional study teams and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.

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. In collaboration with CRO, 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 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 expectation on deliverables and timelines to guide CRO biostatistician 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 meeting or teleconferences with Health Authorities.
  • Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR update, periodic safety update and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings

Preferred Qualifications:
  • PhD in statistics or biostatistics and 7+ years relevant experience in the pharmaceutical / biotechnology industry or MS in Biostatistics or Statistics and 10+ years relevant experience in the pharmaceutical / biotechnology industry
  • Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.
  • Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation.
  • 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
  • Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes
  • Excellent programming skills in SAS and/or R
  • Excellent oral and written communication skills
  • Knowledge of advance clinical trial design concepts and an understanding of clinical/regulatory concepts
  • Ability to work as a part of cross-functional team in a fast paced environment and to work collaboratively with external partners and vendors

What We Offer:
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so