Associate Director, Statistical Programming

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

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, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

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

Who You Are

Associate Director of Statistical Programming will lead the statistical programming activities for multiple studies and programming submission-related activities. In addition to work as a hands-on programmer for various internal requests, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions. 

Responsibilities

• This position will play a crucial role in a specific therapeutic area, offering programming support across various stages of clinical trials to ensure the timely delivery of high-quality outputs. The individual will provide expert-level, hands-on support and technical support to all clinical development programs and regulatory submissions
• Responsibility includes overseeing the quality and management of the CRO’s work, as well as collaborating regularly with Biostatisticians, Clinical Data Managers, Medical Writing, Clinical Operations, Drug Safety, Regulatory and other team members to help enhance process efficiency and quality of statistical outputs
• Provide valuable input into key study documents such as Case Report Forms (CRFs), data management plans, database specifications, Statistical Analysis Plans (SAPs), and other clinical documents
• Provide statistical programming expertise on the production and validation of tables, figures, and listings (TFLs), ensuring that CROs, vendors, and internal staff adhere to the highest quality standards as per Standard Operating Procedures (SOPs)
• Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). Validate and create SDTM, ADaM, and Tables, Figures, and Listings (TFLs), including associated documentation like define.xml
• Oversee programming support for relevant deliverables, such as Investigator Brochures, publications, US, and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation (Define.xml), Reviewer’s Guide (SDRG, ADRG), TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response)
• Collaborate with internal team members effectively to help develop/enhance/maintain global macros, assist in programming infrastructure and processes development
• In addition to hands-on programming, this position may require managing and providing oversight of one or more team members/contractors
• Development of comprehensive project plans, including task breakdowns, timelines, and resource allocation. Create realistic schedules and adapt plans to changing project requirements
• Anticipate potential challenges and devise contingency plans to address unforeseen difficulties. Ensure quality and timely delivery of analysis for our clinical trials

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, BS/BA degree in Statistics, Mathematics, or Computer Science, or other suitable qualification with relevance to the field 
• At least 10 years of Statistical Programming experience in biotech, pharmaceutical industry, or CRO
• Strong hands-on SAS programming skills, expertise in EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical coding dictionaries, controlled terminologies, as well as in industry standards for electronic submission of data to FDA
• A comprehensive understanding of SAS/BASE, SAS/STAT/, SAS/GRAPH and SAS macro languages
• A demonstrable record of strong leadership and teamwork, and ability to work within cross-functional teams. Possesses outstanding interpersonal skills, demonstrating the capability to work both independently and cooperatively within a dynamic team environment
• Proficient in managing multiple projects with a demonstrated ability to prioritize takes, anticipate challenges, pay attention to details, and execute actions effectively, is highly valuable
• Demonstrate a strong sense of accountability and ownership for assigned projects. Take initiative to ensure timely and successful project delivery

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$180,000—$230,000 USD