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 conti