Objectives of the Role

A Senior Data Programmer will act as a lead statistical programmer analyst, provides timely support to the study team on all programming matters according to the project strategies in clinical pharmacology department. As an integral part of a study, the Senior data programmer provides project leadership and programming support for processing data from clinical studies. Critical client project activities are creating NONMEM datasets, CDISC compliant analysis datasets (SDTM, ADaM) according to programming specification, and working closely with Pharmacometricians to create precise data specifications and offer programming support for analyses, such as NCA, population PK models, PK/PD analyses and exposure-response analyses.

Responsibilities

As part of the Clinical Pharmacology, Modeling and Simulation team, the Data Manager will:

• Develop analysis plans, execute and communicate per standard operating practices of Pumas-AI.
• Work closely with clients' teams.
• Prepare reports, data and programs in a manner suitable for regulatory submissions.
• Create and manage datasets and tasks such as non-compartmental and compartmental PK/PD analysis.
• Generate reusable codes to help automate the processes.
• Collaborate with Pumas-AI pharmacometricians by providing datasets/visualization for the modeling of emerging PK and PK/PD data.
• Maintain knowledge of relevant scientific and regulatory industry best practices.
• Prepare formal presentations and written reports with regards to data to Pumas-AI standards.
• Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.

Qualifications and Education Requirements

• Bachelors or MS degree in related fields
• Minimum of 5 years of experience in writing SAS/R codes (preferably R) for Pharmacokinetic/Pharmacodynamic analyses in support of various phases of drug development
• Must be an expert in dataset construction, NONMEM dataset creation, with a strong preference for familiarity with PK and PKPD datasets, R skills are strongly preferred.
• Working knowledge of CDISC, SDTM and ADaM General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred.
• Ability to work independently and as a team member.
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently in a timely manner.
• Must be well-organized and detail-oriented and with good written and verbal communication skills. 

Preferred Skills

• Knowledge on PK/PD data compilation, and data wrangling/handling/cleaning with scripting software SAS, or R (strongly preferred)
• Experience in establishing collaborative working relationships with internal and external stakeholders

About Us

Pumas-AI is a young company led by decades of experience in diverse areas of healthcare and mathematical modeling. With a focused goal on providing better solutions for patient care, be it via pharmaceutical drug development innovation or tools for point of care, Pumas-AI aims to bring value, innovation and efficiency to healthcare. We build technology that converts the power of science into real-world applications with unprecedented speed and accuracy. At the core of everything we do is our commitment to move science forward.

We are a virtual company with team members in several countries. While this means we can work remotely from anywhere, it also means we've developed a unique culture that thrives on transparency, communication, and creativity. Each of us respects the commitments we have outside of work – and the trust and flexibility to attend to them, encouraging a healthy work/life balance.

Pumas-AI is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our culture is one that encourages, supports and celebrates our diversity and looks to bring out the best in each other.

Do the work you love and make an impact in the lives of millions. Join us!

Terms of Employment

Reports to: Director/Senior Director

Location: Remote

Travel Required: None

Position Type: Full-Time

Please send cover letter and CV to careers@pumas.ai.