Reports To: Vice President, Biostatistics
Functional Area: Product Development
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a late-stage clinical biotechnology company with a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts on a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead asset is pacibekitug (also known as TOUR006), a long-acting, fully-human, anti-IL-6 monoclonal antibody. Pacibekitug has previously completed multiple Phase 1 and Phase 2 clinical trials. Tourmaline is developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD), abdominal aortic aneurysm (AAA) and thyroid eye disease (TED). More information about Tourmaline and pacibekitug can be found at www.tourmalinebio.com.
General Responsibilities:
The Senior Director, Statistical Programming leads and manages the statistical programming function to support clinical development programs through all stages of clinical development and regulatory submission. As a key member of the Biostatistics team, the individual provides strategic direction, produces and ensures high-quality deliverables, fosters innovation, and promotes cross-functional collaboration in a fast-paced, science-driven environment.
Key Responsibilities:
- Provide strategic and operational leadership for all statistical programming activities across the clinical development portfolio.
- Oversee the development, validation, and maintenance of programs used for clinical data analysis, reporting, and submission.
- Produce and ensure timely delivery of high-quality statistical programming outputs including tables, listings, figures (TLFs), datasets (e.g., SDTM, ADaM), and submission packages.
- Collaborate with biostatistics, clinical data management, medical writing, and regulatory affairs to ensure alignment of programming deliverables with clinical and regulatory objectives.
- Lead the development and maintenance of programming standards, tools, and best practices in accordance with CDISC guidelines and regulatory requirements (e.g., FDA, EMA).
- Oversee and manage the statistical programming resources, including external vendors and contractors, supporting the clinical development portfolio.
- Contribute to protocol design, statistical analysis plans (SAPs), and other clinical development documents as needed.
- Ensure effective resourcing, budget oversight, and vendor management for programming activities.
- Stay abreast of industry trends, tools, and regulatory guidance relevant to statistical programming and data standards.
Education and Licensure:
- Master’s or Ph.D. in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
Experience and Attributes:
- 15+ years of experience in statistical programming within the pharmaceutical or biotech industry, with at least 8 years in a leadership role.
- Extensive experience in SAS programming and familiarity with R or other statistical software.
- Deep knowledge of CDISC standards (SDTM, ADaM), FDA/EMA submission requirements, and ICH guidelines.
- Proven track record of successful regulatory submissions and late-phase development.
- Experience managing internal teams and external vendors/CROs/FSP.
- Excellent communication, organizational, and leadership skills.
- Ability to thrive in a dynamic, innovative biotech environment with limited structure and high expectations.
- Strong strategic thinking with a hands-on, problem-solving mindset.
Base Salary Range: $242,900 – $291,400 based on candidate professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
