Associate Director/Director, Statistical Programming

Location
San Francisco, California
Posted
Jul 04, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
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 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 Associate Director/Director, Statistical Programming, will lead the statistical programming activities for multiple studies and the programming submission-related activities. In addition to work as a hands-on programmer for various internal requests, this individual will also need to manage, guide, and validate the CRO programming team and work collaboratively with internal and external teams in results reporting and regulatory submissions.

Responsibilities:
  • Lead and manage statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency
  • Manage CRO to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards by reviewing CRO deliverables and perform acceptance check and validation
  • Manage, review, and/or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations, and regulatory query responses, covering multiple studies
  • Collaborate with external alliances for all programming-related activities; ensure successful and effective coordination and communications
  • Perform hands-on SAS programming to generate TFLs to support ad hoc requests and decision making
  • Represent the statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines
  • Review data management documents (such as CRF specification, data transfer agreements, data management plan, annotated CRF), SDTM specification, ADaM specification, Statistical Analysis Plan, and TFL shells to provide statistical programming feedback; perform other tasks as needed, including UAT of clinical databases, in support to the data management and operation teams
  • Identify, develop and maintain statistical programming standards, processes, and SOPs


Education, Experience & Skills Requirements:
  • MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience, or BS in Statistics, Computer Science, or a related field with 12+ years of relevant experience
  • Minimum of 5 years of experience as a lead statistical programmer
  • Extensive knowledge of CDISC standards and Pinnacle 21 validator
  • Experience in NDA/BLA submission
  • Experience of CRO oversight preferred
  • Advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
  • Experience in clinical development statistical programming methods and processes in industry setting required
  • Demonstrated proficiency and expertise in SAS programming for data analysis in clinical trials
  • Ability to manage multiple projects in a fast-paced environment


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.