Associate Director, Statistical Programming

MBX Biosciences; Burlington (MA); Híbrido; USD 140.000 - 210.000; Jornada completa

Descripción de la vacante

MBX Biosciences, Inc. in Massachusetts is seeking an Associate Director, Statistical Programming to lead statistical programming for clinical trials, ensure the quality of deliverables, and oversee external vendors.

The role supports regulatory submissions and internal process improvements across multiple compounds. You will manage global submission activities, maintain SAS macros and workflows, contribute to SAPs and publications, and mentor cross-functional teams in a fast-paced,

Formación

• 8+ years of statistical programming experience in biotech or pharmaceutical industry.
• Advanced degree (PhD, MS, or equivalent) in life sciences, biostatistics, mathematics, computer science, or a related field.
• Proficient in SAS programming (Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) with a solid database understanding.
• Experience with R and Python for advanced data visualization and analysis.
• Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and electronic submissions (eSub) under eCTD.
• Proven ability to lead programming activities and oversee CRO deliverables.
• Strong analytical, organizational, and communication skills; detail-oriented; capable of managing multiple priorities.
• Demonstrated leadership in cross-functional teams, global submissions, and database management.

Responsabilidades

• Oversee and execute statistical programming deliverables for planned analyses and regulatory responses across multiple compounds and studies.
• Lead global submission activities, acting as a programming expert to support strategy planning and regulatory communications.
• Manage CROs and contractors to ensure high-quality deliverables, timelines, and budget adherence.
• Develop and validate reproducible programs to produce outputs for integrated trial reports, adhering to SAPs and regulatory conventions.
• Maintain and enhance the internal SAS macro library and database.
• Provide programming input for SAPs, publications, scientific presentations, regulatory submissions, and promotional materials.
• Review CRFs, SAPs, TLFs, and dataset specifications (SDTM/ADaM).
• Serve as a study-team lead for statistical programming, communicating issues clearly to cross-functional teams.
• Contribute to programming standards, macros, SOPs, and process improvements within Biometrics.
• Other responsibilities as assigned.

Conocimientos

SAS programming

R & Python

CDISC SDTM/ADaM

eCTD submissions

CRO oversight

Data management

Leadership

Regulatory experience

Educación

PhD or MSc in life sciences/biostatistics/related field

Herramientas

SAS

R

Python

Descripción del empleo

Working with Us

MBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. Our mission is to transform the lives of people impacted by endocrine and metabolic disorders through our novel precision peptides.

Leveraging our proprietary Precision Endocrine Peptides (PEPs)™ platform, we are pioneering technology designed to overcome key limitations of existing therapies and enhance efficacy, tolerability, safety and convenience. Our team is advancing a pipeline of novel candidates with clinically validated targets, established endpoints for regulatory approval, and strong market potential.

Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform.

If you're passionate about advancing innovative treatments for patients and shaping the future of precision peptide therapeutics, this is your chance to make a real impact alongside a fast-paced, growing, mission-driven team. To learn more, visit our website mbxbio.com and follow us on LinkedIn.

Position Summary

MBX is seeking an Associate Director, Statistical Programming to lead and contribute to 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 and expanding SAS macros, R workflows, and clinical data repositories.

What You'll Do

• Oversee and execute statistical programming deliverables for planned analyses, including study monitoring, data reviews, clinical study reports, data integrations, and rapid 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; ensure all programming deliverables meet timelines, quality standards, and regulatory expectations (eg, ICH, FDA, EMA).
• Manage CROs and contractors to ensure compliance, high-quality deliverables, adherence to timelines, and budget alignment.
• Develop and validate reproducible, well-documented statistical programs to produce outputs for integrated scientific reports of clinical trial results, ensuring adherence to protocols and Statistical Analysis Plans (SAPs), and regulatory reporting conventions.
• Maintain and enhance the internal SAS macro library and database.
• Provide statistical programming input for SAPs, publications, scientific presentations, regulatory submissions, and promotional materials.
• Review Case Report Forms (CRFs), CRF annotations, SAPs, Table, Listing, and Figure (TLF) shells, TLF outputs, dataset specifications (SDTM and ADaM).
• Serve as a lead for statistical programming within study teams, effectively communicating statistical and programming issues to development teams.
• Contribute to the development of programming standards, macros, SOPs, and process improvements within the Biometrics function
• Other responsibilities as assigned.

What You Bring

• 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, 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
• Experience with R and Python preferred for advanced data visualization and analysis.
• Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and electronic submissions (eSub) under eCTD specifications.
• 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 database management.

Travel & In Office Presence

You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.

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.