What are the responsibilities and job description for the Associate Director, Statistical Programming position at MBX Biosciences, Inc.?
Position Summary
MBX is seeking an Associate Director, Statistical Programming to lead and contribute to the statistical programming and analysis of clinical trial data. This role is integral to the design, execution, and interpretation of analyses for clinical trials and related research activities. The Associate Director will ensure the quality and accuracy of statistical deliverables, oversee external vendor performance, and contribute to internal process improvements, including maintaining SAS macros and safety databases.
Key Responsibilities
You will be expected to travel periodically based on the needs of the business to the extent requested by the Company including attendance at Together Weeks, Together Days and functional meetings as requested by the Company.
Company Overview
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
EEO Statement
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
MBX is seeking an Associate Director, Statistical Programming to lead and contribute to the statistical programming and analysis of clinical trial data. This role is integral to the design, execution, and interpretation of analyses for clinical trials and related research activities. The Associate Director will ensure the quality and accuracy of statistical deliverables, oversee external vendor performance, and contribute to internal process improvements, including maintaining SAS macros and safety databases.
Key Responsibilities
- Oversee and execute statistical programming deliverables for planned analyses, including study monitoring, clinical study reports, data integrations, and responses to regulatory queries across multiple compounds and studies.
- Lead global submission activities, acting as a programming functional and technical expert to support submission strategy planning and regulatory communications.
- Manage CROs and contractors to ensure compliance, high-quality deliverables, adherence to timelines, and budget alignment.
- Develop and validate statistical programs to produce outputs for integrated scientific reports of clinical trial results, ensuring adherence to protocols and Statistical Analysis Plans (SAPs).
- Maintain and enhance the internal SAS macro library and safety database.
- Provide statistical input for SAPs, publications, scientific presentations, and promotional materials.
- Review Case Report Forms (CRFs), CRF annotations, SAPs, Table, Listing, and Figure (TLF) shells, and TLF outputs.
- Serve as an indication lead for statistical programming within study teams, effectively communicating statistical and programming issues to development teams.
- Create and review derived dataset specifications and the related analysis datasets.
- Other responsibilities as assigned.
- 8 years of statistical programming experience in the biotech or pharmaceutical industry, with a preference for expertise in endocrine and metabolic disorders.
- Advanced degree (PhD, MS, BS, etc.) in life sciences, biostatistics, mathematics, computer science, or a related field preferred.
- Proficient in SAS programming (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) with a solid understanding of database systems.
- Extensive experience with CDISC standards (SDTM, ADaM) and electronic submissions (eSub).
- Proven ability to lead programming activities and provide oversight of CRO deliverables.
- Strong analytical, organizational, and communication skills, with a keen eye for detail and the ability to manage multiple priorities in a dynamic, fast-paced environment.
- Demonstrated leadership in cross-functional teams, experience with global submissions, and knowledge of safety database management.
You will be expected to travel periodically based on the needs of the business to the extent requested by the Company including attendance at Together Weeks, Together Days and functional meetings as requested by the Company.
Company Overview
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
EEO Statement
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.