Sr. Manager/Associate Director/Director, Statistics & Statistical Programming
Contineum Therapeutics • United States
Posted: June 29, 2026
Job Description
Company Overview:
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit www.contineum-tx.com.
Job Summary:
The Senior Manager / Associate Director / Director, Statistics and Statistical Programming, will be responsible for various analysis, programming and validation activities to support clinical trials from early-stage through regulatory submission. They will work closely with Biostatistics, Clinical Data Management, Clinical Operations, and external CRO partners to ensure high-quality, compliant deliverables that support study reporting and regulatory submissions. This will be a hybrid programmer / statistician position, with ability to specialize in either as the department grows.
Job Location: This role can be hybrid out of the San Diego office or fully remote; preference for a candidate based on the West Coast of the United States with some travel to the San Diego office. Visa support is NOT available for this position.
- Serve as the lead statistical programmer for clinical studies, providing technical leadership and project management oversight for all programming activities
- Oversee vendors that develop, validate, and maintain SAS programs and associated documentation to generate high-quality regulatory-compliant deliverables, including SDTM and ADaM datasets, define.xml files, reviewer’s guides, tables, listings, and figures (TLFs)
- Collaborate with biostatisticians and cross-functional study teams to develop and ensure implementation of Statistical Analysis Plans (SAPs) and programming specifications
- Oversee the creation, review, and maintenance of programming plans, dataset specifications, TLF specifications, review guides, validation documentation, and other required study documentation
- Provide expert-level support and oversight for CDISC implementation, including SDTM and ADaM standards, ensuring compliance with regulatory requirements and industry best practices
- Oversee conformance checks using Pinnacle 21 and other validation tools; identify, troubleshoot, and resolve data and submission issues to ensure submission-ready deliverables
- Generate ad hoc analyses and reports to support Clinical Development, Medical Affairs, Drug Safety, and other functional areas
- Support interim analyses, database locks, clinical study reports, publications, and global regulatory submissions
- Actively participate in development of exploratory analyses, including defining questions of interest and suggesting solutions
- Oversee and manage CRO programming activities, including review, quality control, and acceptance of outsourced deliverables; provide guidance and solutions for programming-related issues
- Contribute to the development, implementation, and continuous improvement of departmental standards, SOPs, work instructions, and programming best practices
- Ensure all statistical programming deliverables comply with company standards, regulatory requirements, and applicable industry guidelines
- Collaborate effectively with internal teams, external vendors, and regulatory partners while communicating project status, risks, and solutions
- Maintain complete and accurate programming records and documentation in accordance with company procedures and submission requirements
- Perform other statistical programming and biometrics-related duties as assigned
- Graduate degree required in Statistics, Biostatistics or closely related fields
- Minimum of 3-5 years of experience in pharmaceutical/biotech with experience programming in a clinical trial environment to support regulatory submissions
- Expert level of SAS programming skills; knowledge of some additional programming languages (e.g. R, Python, Spotfire) a plus
- Expert knowledge regarding clinical trial design, data collection/cleaning, regulatory requirements and their relationship with data analysis
- Familiar with ICH guidelines, possess advanced knowledge of submission requirements and standards
- Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM, and ability to oversee vendors creating CDISC outputs
- Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests; ability to investigate data and add value through exploratory analyses with minimal prompting
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
- Strong organizational and multitasking skills
- Excellent communication and interpersonal skills
Additional Content
Company Overview:
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit www.contineum-tx.com.
Job Summary:
The Senior Manager / Associate Director / Director, Statistics and Statistical Programming, will be responsible for various analysis, programming and validation activities to support clinical trials from early-stage through regulatory submission. They will work closely with Biostatistics, Clinical Data Management, Clinical Operations, and external CRO partners to ensure high-quality, compliant deliverables that support study reporting and regulatory submissions. This will be a hybrid programmer / statistician position, with ability to specialize in either as the department grows.
Job Location: This role can be hybrid out of the San Diego office or fully remote; preference for a candidate based on the West Coast of the United States with some travel to the San Diego office. Visa support is NOT available for this position.
- Serve as the lead statistical programmer for clinical studies, providing technical leadership and project management oversight for all programming activities
- Oversee vendors that develop, validate, and maintain SAS programs and associated documentation to generate high-quality regulatory-compliant deliverables, including SDTM and ADaM datasets, define.xml files, reviewer’s guides, tables, listings, and figures (TLFs)
- Collaborate with biostatisticians and cross-functional study teams to develop and ensure implementation of Statistical Analysis Plans (SAPs) and programming specifications
- Oversee the creation, review, and maintenance of programming plans, dataset specifications, TLF specifications, review guides, validation documentation, and other required study documentation
- Provide expert-level support and oversight for CDISC implementation, including SDTM and ADaM standards, ensuring compliance with regulatory requirements and industry best practices
- Oversee conformance checks using Pinnacle 21 and other validation tools; identify, troubleshoot, and resolve data and submission issues to ensure submission-ready deliverables
- Generate ad hoc analyses and reports to support Clinical Development, Medical Affairs, Drug Safety, and other functional areas
- Support interim analyses, database locks, clinical study reports, publications, and global regulatory submissions
- Actively participate in development of exploratory analyses, including defining questions of interest and suggesting solutions
- Oversee and manage CRO programming activities, including review, quality control, and acceptance of outsourced deliverables; provide guidance and solutions for programming-related issues
- Contribute to the development, implementation, and continuous improvement of departmental standards, SOPs, work instructions, and programming best practices
- Ensure all statistical programming deliverables comply with company standards, regulatory requirements, and applicable industry guidelines
- Collaborate effectively with internal teams, external vendors, and regulatory partners while communicating project status, risks, and solutions
- Maintain complete and accurate programming records and documentation in accordance with company procedures and submission requirements
- Perform other statistical programming and biometrics-related duties as assigned
- Graduate degree required in Statistics, Biostatistics or closely related fields
- Minimum of 3-5 years of experience in pharmaceutical/biotech with experience programming in a clinical trial environment to support regulatory submissions
- Expert level of SAS programming skills; knowledge of some additional programming languages (e.g. R, Python, Spotfire) a plus
- Expert knowledge regarding clinical trial design, data collection/cleaning, regulatory requirements and their relationship with data analysis
- Familiar with ICH guidelines, possess advanced knowledge of submission requirements and standards
- Advanced knowledge of CDISC standards, including CDASH, SDTM and ADaM, and ability to oversee vendors creating CDISC outputs
- Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests; ability to investigate data and add value through exploratory analyses with minimal prompting
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
- Strong organizational and multitasking skills
- Excellent communication and interpersonal skills