Senior Manager / Associate Director / Director, Statistical Programming

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

We offer a competitive total compensation package and work in a supportive team environment. The anticipated salary range for candidates who will work in San Diego, CA, is $155,000 - $230,000 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including:

• 90% employer-covered benefits
• Flexible PTO
• A very generous holiday schedule that includes a week off in August and time off around the winter holidays
• A well-stocked kitchen with snacks and beverages
• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match
• The comprehensive wellness program includes medical, dental, vision, and LTD coverage