Director of Statistical Programming
About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrodinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.
Job Description:
The Director of Statistical Programming will be responsible for leading all programming-related activities for our clinical development programs. This position will work collaboratively with cross-functional teams and external CRO to ensure timely delivery of programming deliverables while maintaining quality standards and compliance with regulatory requirements. The Director will also play a crucial role in developing and implementing programming strategies to support clinical trials, ensuring efficient data management and analysis, and providing expert guidance on statistical programming as well as hands-on programming support.
Essential Job Functions:
* Lead and manage SAS programming activities to ensure that they meet timelines, budget, and quality standards in accordance with Company study contracts and established standards and procedures.
* Provide statistical programming oversight and hands-on programming support for various clinical studies.
* Review and quality check programming work provided by the CRO, such as timelines, QC outputs, datasets, CDISC package, and programming-related documents.
* Collaborate effectively with biostatisticians to develop data specifications, analysis datasets, and analysis outputs per requests for internal medical monitoring, CSR, ad-hoc analysis, publication, and submission needs.
* Support the development and review of study documents, including protocols, statistical analysis plans, clinical study reports, and those supporting database design and data collection.
* Work with data managers to generate ongoing outputs that support data cleaning and enhance data integrity.
* Establish and maintain programming standards, processes, and best practices that ensure consistency and quality across programming deliverables.
* Develop or evaluate software tools/utilities and procedures to improve programming efficiency, quality, and cross-functional collaboration.
Qualifications:
Required
* Master's degree or higher in statistics, biostatistics, or a related field.
* 10 + years of experience in statistical programming in the pharmaceutical or biotechnology industry, including experience in clinical trial data analysis and reporting.
* Strong proficiency in statistical programming languages, such as SAS or R.
* Strong working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
* Ability to work independently as well as lead programming teams.
* Experience managing and working with CRO.
* Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams and external partners.
Desired
* Experience with small clinical trials, including phase I and II studies.
* Experience in leading integrations (ISE/ISS), regulatory submissions, or similar activities.
* Experience working in a fast-paced and dynamic environment, with the ability to adapt to changing priorities and timelines.
Cultural Fit:
Our culture is collaborative, one where people enjoy coming to work. We are a small, entrepreneurial company where everyone pitches in and works together to do whatever it takes to get things done. Our team is passionate, enthusiastic, and committed.
We have a fast-paced, high accountability environment. We have a flat organization, and our leaders lead through influence and interpersonal skills, not command and control. Everyone on the team, including our CEO, is an individual contributor.
We seek an individual for this position who shares our values and our enthusiasm about bringing new medicines to the patients and families that need them. We seek someone who will enjoy working in a small company environment and be motivated by the opportunity to directly influence and help shape the future direction and culture of our company.
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees' development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients' lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.