Lead Clinical Data Programmer

Are you a seasoned Clinical Data Programming professional looking for an opportunity to join an industry leading data technology organisation in the clinical research space? Clario are looking for a Lead, Clinical Data Programmer to join our well established team in India, working alongside a global team of data specialists to provides our customers with best in class data to support the development of life changing therapies from clinical trials.

What we offer

• Competitive compensation + commission scheme

• Attractive benefits (security, flexibility, support and well-being)

• Engaging employee programs

• Technology for hybrid working and great onsite facilities

What you will be doing

Lead and Mentor a team of Clinical Data Programmers, Create and test SAS code used for standard and non-standard data file creation; Review Clario standard and non-standard data specifications.

• Attend client meetings as appropriate to understand data collection requirements.

• Review standard CLARIO and non-standard data specifications and interact with the Data Manager (DM) to finalize specifications.

• Develop programs to create Clario standard and non-standard data files.

• Participate in the validation of encoding programs which generates CLARIO standard and non-standard data files.

• Performing ad-hoc programming activities utilizing raw data based on internal and external requests for:

a. Esoteric quality control checks requested by QC.

b. Data resolution/Mining.

c. Other client requirements.

• Get exposed to all modalities.

• Review User Requirements and create, review and approve Functional and Technical Specifications.

• Work with data management in providing programming support for DM activities including data review.

• Prepare and participate in internal and external audits.

• Represent the service line through the NPI (New Product Initiative) process.

• Identify opportunities to improve the methodology and provide practical solutions for problems.

• Contribute to the development of best practices to improve quality, efficiency and effectiveness.

• Drive client deliverables by performing the role of CDP SME when attending Project Management, Data Management or CDO meetings.

• Organize team resources to meet client needs.

• Lead and Mentor a team of Clinical Data Programmers:

• Develop the orientation and training plan for assigned Clinical Data Programing personnel.

• Oversee training of new Clinical Data Programmers.

• Assist with orientation and training of personnel as determined by management.

• Contribute to process development. Review and development of SOPs and associated documents related to Clinical Data Programming activities.

• Complete administrative tasks as needed within Clinical Data Programming.

• Mentoring other Clinical Data Programming resources.

• Participate in new hire interviews and provide feedback to management

What we look for

• BS/BA Degree in Life Sciences or related field preferred or BS/BA Degree in computer sciences or related field

• SAS ADVANCED certified

• Ideally five or more years of experience in a pharmaceutical company or a CRO as a SAS Programmer - experience in SAS/BASE, SAS/MACRO and SAS/SQL products and procedures and one or more years of experience in database design and data structures

• Understanding of the pharmaceutical drug development process, as gained through a minimum of five years of experience in the pharmaceutical or healthcare industry.

• Strong organization, analytical and communication skills.

• Detail-oriented

• Extensive experience in implementing CDISC SDTM and Define standards including EG, CO, DM, RE, VS, SUPP CDISC SDTM domains.

• Experience with Windows and Microsoft Office products preferred.

• Strong written and verbal communication skills.

• Fluency in English (spoken and written).

• Experience with another programming languages is a plus.

• Proven experience working with large, complex real-world data sets (more specifically, patient data)

• Knowledge of technical and regulatory requirements related to the role.

• Excellent time management skills, contributing to multiple projects with competing timelines.

• Leadership/Mentoring skills: Proven ability to motivate people, instill accountability and achieve results.

• Prior leadership experience a plus.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.