Director, Statistical Programming

Alkeus Pharmaceuticals•Cambridge, MA

19h•$230,000 - $245,000•Onsite

About The Position

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S. The Statistical Programming Director is responsible for driving the execution and oversight of the related activities across clinical studies, ensuring high-quality, compliant, and timely deliverables. This Director leads the development and implementation of CDISC-compliant datasets (SDTM, ADaM) and tables, figures, and listings (TFLs), while supporting both planned and ad-hoc analyses to address evolving clinical and business needs. The Director collaborates closely with biostatisticians and cross-functional teams to translate study objectives into efficient programming solutions, and serves as a key point of oversight for external partners, including Contract Research Organizations (CROs), ensuring consistency, accuracy, and adherence to regulatory standards. The Director also performs independent validation and quality control of programming outputs and manages multiple concurrent projects, prioritizing workstreams to meet critical timelines and support data-driven decision-making.

Requirements

PhD in Statistics/Biostatistics
12+ years of experience in biotech, pharma or related industries
Hands-on experience with programming for clinical development
Direct experience with regulatory submissions (NDAs, BLAs, and other filings) with experience in ISS/ISE
Advance expertise with SAS programming and comprehensive knowledge of CDISC standards
Working knowledge of ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Proficiency in SAS and/or R

Nice To Haves

Entrepreneurship spirit with a passion to build, learn and evolve with the team
Highly organized and detail oriented with a passion to deliver quality results
Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
Evidence of "hands-on" experience and expertise
Proven and successful track record as a team-player and collaborator in small working environments
Highest levels of professionalism, confidence, personal values and ethical standards

Responsibilities

Lead statistical programming efforts for clinical studies to ensure clarity, integrity, and compliance with internal and external standards
Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making
Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
Conduct independent validation and quality checks of statistical programming deliverables from CROs
Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines
Deliver on other related projects as assigned.