Job Description
Associate Director, Statistical Programming
Remote – United States
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
BridgeBiois 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 todays discoveries into tomorrows 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.
who you are
The Sr. Manager/Associate Director, Statistical Programming is a member of the Biostatistics team and is an individual contributor in charge of SAS programming production and validation activities. Responsibilities include 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. Successful candidates will oversee the quality and management of the CROs work, as well as collaborate 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.
responsibilities
- 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), Reviewers 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
- For the Senior Manager role, pharmaceutical industry, or CRO is required, while the Associate Director position necessitates a minimum of 10 years of experience
- 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