Senior Manager/Associate Director, Biostatistics

Location
San Francisco, California
Posted
Jul 30, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Contract
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 aims 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

Who You Are:

The Senior Manager/Associate Director of Biostatistics is responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. The successful candidate will also interact with internal and external cross-functional study teams, supporting interactions with Health Authorities globally, 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
  • Guide to study team on all aspects of statistical activities; collaborates closely with a data manager to ensure high-quality data
  • Work 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: Establish procedures through regular interaction, setting expectations on deliverables and timelines to guide CRO biostatisticians and statistical programmers; ensure deliverables are accurate and delivered according to the timelines
  • Global Health Authority Interaction: Contribute 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 updates, and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings


Education, Experience & Skills Requirements:
  • 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
  • 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 the 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


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


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.