Associate Director/Director of Statistical Programming

Waltham, MA, United States

Description

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 Schrödinger, 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 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 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 Associate Director /Director of Statistical Programming will lead programming activities for the clinical studies according to the study requirements and timelines. This position will work collaboratively with study statisticians, cross-functional team, and external CRO to ensure timely and high-quality delivery of programming outputs in compliance with regulatory standards. Responsibilities include providing oversight and quality assurance of vendor work, offering hands-on programming support, developing and implementing programming strategies for clinical trials, and ensuring efficient data management and analysis.

Essential Job Functions:

* Lead and manage SAS programming activities to ensure that they meet timelines, and quality standards.* Oversee the programming work provided by the CRO. Conduct validation and quality control of CRO deliverables (SDTMs, ADaMs, TLFs, Define Packages, and programming-related documents) to ensure accuracy, consistency, and compliance with regulatory standards.* Provide hands-on programming support for various clinical studies, including study reports, ad hoc/post hoc analyses, exploratory analyses, conference, and publications, DSUR, safety review, regulatory submissions, etc.* Collaborate effectively with study statisticians and CRO to develop programming 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-related documents, including but not limited to protocols, statistical analysis plans, CRFs, data transfer specification, and those supporting database design and data collection.* Work with study team to generate ongoing outputs that support data review and 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.* 7 + 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 in regulatory submissions, integrated analyses (ISE/ISS), 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.

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