ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Sr. Statistical Data Programmer on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

This role reports to the Manager, Statistical Programming, and above
Produces complex statistical analysis using SAS/R according to relevant standard operating procedures
Ensuring compliance to SOPs and internal process for the project managed
Programming analysis dataset without specifications and review of SAS programs in the designated clinical trail
Develop SDTM/ADaM specifications as per the company or client standards
Ensure the project team delivers the projects within agreed timelines and quality Ability to lead multiple studies (e.g., CSR, DMC, PSUR/DSUR, etc.)
Developing SAS Programs for the complex statistical analysis of study data, including analysis of datasets, tables, listings, and figures
Programming according to CDISC SDTM and ADaM datasets
Review Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines
Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines.

Requirements:

Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects.

Extensive experience within the pharmaceutical industry with clinical programming and clinical development processes across therapeutic areas.
Comprehensive knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, and analysis the requirements for clinical programming projects.
In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc.
Proficient in Microsoft Office Suite, g., Word, Excel, PowerPoint, etc.
Excellent written and verbal communication skills, collaborations, and interpersonal
Strong experience in ADaM programming (Development and Validation)
Strong experience in TLF programming (Development and Validation)
Strong experience in SAS Programming
Good Knowledge or Strong Experience in SAS Macro
It is preferable to have R/Python experience (Not a mandatory requirement) Should be a MBBS/MD with 2- 4 years of experience as Medical Reviewer for ICSRs.

Our Benefits:

• Daily Meal Subsidy
• Flexible working hours and work from home privileges.
• HMO coverage up to maximum of 2 dependents subsidy
• Life and accident Insurance
• 15 Sick Leave and 15 Vacation Leave
• Monetized leave
• Performance Based Annual Salary Increase
• Clothing Allowance
• Rice Allowance
• Laundry Allowance

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity

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