Principal Statistical Programmer

Your mission

As a Principal Statistical Programmer, you will oversee and be accountable for all statistical programming deliverables. You'll ensure compliance with industry standards and regulatory guidelines, manage external vendors, work closely with the biostatisticians and collaborate with cross-functional teams to facilitate seamless analysis and reporting of our clinical trials. This role is perfect for a dynamic leader who thrives in a fast-paced, innovative environment and is critical in supporting the advancement of novel therapies through effective statistical programming strategies. You will work closely with the Global Head of Biostatistics & Data Management, playing a key role in ensuring the integrity and quality of clinical trial data collection and reporting in accordance with global regulatory standards.
In a small biotech there is a need to be flexible. The ideal candidate would also have the ability to back up the lead statistician and possibly develop into the role.

Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (, reviewer’s guide, annotated CRFs) conforms to SOPs and to regulatory specifications
Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.
Ensure timely delivery of all statistical deliverables for each study assigned
Empowered to work independently (and manage external vendors) on task for database management for completed and ongoing clinical trials, and perform data and statistical analysis for different stakeholders in the company and for regulatory submissions
Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items
Support statistical analysis tasks
Follow departmental SOPs and processes for operational excellence
Lead statistical programming activities for regulatory submissions following CDISC standards
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan
Take ownership for the completion of SDTM and ADAM specifications for assigned studies
Provide mentorship to junior data management staff, promoting a culture of excellence and continuous improvement

Your profile

Bachelor’s degree in a relevant field; advanced degree in biostatistics strongly preferred
10+ years of experience in biostatistical analysis and statistical programming within a mix of CRO, biotech, or pharmaceutical industry environment
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Strong SAS programming and graphic programming skills
Able to guide the successful completion of major programs and projects
Strong analytical and communication skills
Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology in relevant therapeutic areas
Demonstrated ability to manage multiple projects simultaneously while maintaining quality and meeting deadlines
Excellent leadership, communication, and collaboration skills
Entrepreneurial mindset with the ability to adapt to changing priorities and environments
A very good cultural fit with Immunic's team and values, along with cross-cultural experience

Why us?

Join us and be part of a company where your work directly contributes to our mission of improving patient care through groundbreaking research. Immunic offers a stimulating work environment where innovation and collaboration are valued. We provide competitive compensation, comprehensive benefits, and opportunities for professional growth.

About us

Immunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: %681222% %%techsoftware%%

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