Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

We are seeking a Clinical Programmer with a strong desire to initiate, lead, drive and improve the Data Management/Clinical programming infrastructure and processes of our growing company. This position offers a unique opportunity to initiate and define clinical programming processes in our dynamic and nimble environment while working with and supporting a variety of teams, primarily Data Management, Clinical Operations, Machine Learning and Comp Bio departments. This “first-in-role" position will report directly to the Head of Data Management but offers a unique opportunity for involvement of the clinical programming team. 

Job Description

· Expected to work independently and determine/develop functional output for multiple teams

· Coordinates with Data Managers regarding timelines and deliverables to ensure all SAS programs are as expected 

· May be asked to support and assist the stats programming team and other departments with “one-off” programming needs and requests 

· Provides advanced knowledge of the clinical data programming development life cycle

· Designs, writes, validates and maintains programs to meet specifications. Programs Non-EDC System Data Checks and SAS or R Data Listings to detect data quality issues for the study team 

· Creation of SAS or R programs to manage the import/export of data from the EDC and 3rd party vendors and labs 

· Independently manage SAS or R processes and applications while evaluating for improvements; lead working groups to develop and implement new processes and applications 

· Responsible for the development, review and implementation of SOPs, templates and processes relevant for clinical programming and other departmental and/or cross functional initiatives as appropriate 

· Utilizes experience and leadership skills to provide guidance to other team members.

· Takes ownership of resourcing team into prioritized deliverables. 

· As our programming resources grow, this role will have supervisory responsibilities 

Qualifications

· Bachelor’s or Master’s degree in computer science, life sciences or related field required (In lieu of a Bachelor’s Degree, completion of a certified database training program/course work and six years (total) of relevant experience in data management and system validation will be accepted) 

· Ability to independently develop innovative and complex SAS or R programs to support activities including, but not limited to, data review and reporting 

· 1-3 years SAS or R direct programming experience in pharmaceutical or biotech development or CRO environment required (or 1 year with Master’s degree) 

· Working knowledge and solid understanding of database organization and how to extract data in order to generate listings and reports 

· Knowledge of clinical research, FDA & ICH, GCP, and related reg requirements and submission data packages 

· SAS Certified Professional considered a plus 

 
KNOWLEDGE, SKILLS & ABILITIES: 

· Ability to wear many hats and adjust swiftly to changing priorities and completing deliverables

· Experience working with SAS datasets from a variety of EDC platforms and data from Smartsheet a plus 

· Knowledge of CDISC standards including SDTM/ADaM and their implementations 

· Ability to work in group setting and independently; ability to adjust to changing priorities 

· Excellent attention to detail and orientation toward meticulous work 

· Strong communication skills, both verbal and written 

· Strong documentation and organizational skills while projecting a professional and positive attitude 

· Strong interpersonal skills with demonstrated capability of working on multiple projects simultaneously. 

Additional Information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***