Summer Intern - Biostatistics, Clinical Dev

At Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases that others often overlook. We believe that where empathy and innovation meet, a better life can begin for people living with neurological diseases. Our team of experts from a wide variety of disciplines and experiences is driven by our shared conviction that innovative science translates into therapeutic possibilities for patients, who are at the heart of everything we do.

Harmony Biosciences culture is defined by our core values - keeping patients at the heart of all we do, acting with integrity and ethics, working with a one-team attitude, leading with the science as we identify clinical possibilities, and delivering excellence.

This summer internship at Harmony offers a unique perspective into a rare-disease focused biotech company. Our internship program will provide you the opportunity to work on real-world projects, as well as network with people at Harmony through various events and activities.

Summary of Internship:

This position will work on the Biostatistics team at Harmony. The Biostatistics team is responsible for ensuring efficient and accurate information processing to ensure data integrity, quality, and efficiency and is accountable for the statistical and statistical programming soundness of all statistical input and deliverables for assigned projects.

The Biostatistics team collaborates with the Clinical team on clinical trial design, available statistical methodologies, and their application in drug development. The Biostatistics team also works closely with external Contract Research Organizations (CROs) and other vendors and provides support, sharing statistical and statistical programming expertise for clinical development projects and studies.

Summary of Internship:

This position will work on the Biostatistics team at Harmony. The Biostatistics team is responsible for ensuring efficient and accurate information processing to ensure data integrity, quality, and efficiency and is accountable for the statistical and statistical programming soundness of all statistical input and deliverables for assigned projects.

The Biostatistics team collaborates with the Clinical Development team on clinical trial design, available statistical methodologies, and their application in drug development. The Biostatistics team also works closely with cross-functional team members (including Regulatory Affairs, Medical Writing, and Clinical Operations) and external Contract Research Organizations (CROs) and other vendors and provides support, sharing statistical and statistical programming expertise for clinical development projects and studies.

This internship will work on one or more projects in the areas of Biostatistics, including the following types of tasks.

• Review project and study documents, including the following:

1. Statistical Analysis Plans (SAPs) and Table, Listing, and Figure (TLF) shells

1. Programmed TLFs

1. Electronic Case Report Forms (eCRFs), edit check specifications, database design specifications, Data Transfer Agreements (DTAs), and other Data Management documents

• Review of datasets (including SAS datasets), using an open-source software language such as R, Python, or possibly Julia (with R being preferred)

• Example special internship projects (depending on applicability and business need) might include the following:

1. Conducting programmatic simulations (e.g., using R, Python, or possibly Julia - with R being preferred)

1. Creating a software program to help identify data "outliers" and/or potentially erroneous data

1. Creating ad hoc summaries and analyses for one or more ongoing projects/studies.

There may also be other projects and initiatives within the team requiring Biostatistics intern support.

Requirements:

• Minimum age for all candidates must be at least 18 years or older
• Must be enrolled in an accredited college or university as a graduate student
• A Statistics, Biostatistics, or a related major and/or coursework is strongly preferred.
• Must be proficient in use of MS Excel, MS Power Point, MS Teams
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
• Candidates must have strong written and verbal communication skills.

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.