Principal Statistical Programmer

4 weeks ago

Bengaluru Karnataka, India ClinChoice Full time

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 Principal Statistical Programmer on a permanent basis. You will work 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**:

- Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
- Develop SDTM specifications and generate SDTM datasets using SAS.
- Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters and Manuscripts.
- Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
- Create electronic submission package to FDA, g., define.xml or define.pdf following FDA guidelines with minimum supervision.
- Analyze information and develop innovative solutions to programming and data analysis challenges.
- Actively communicate with statisticians for statistical input and analysis interpretation.
- Follow and reinforce regulatory agency requirements during daily job.
- Serve as a programming team lead and contribute to department initiative.
- Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
- Review draft and final production deliverables for project to ensure quality and consistency.

**Education, Experience and Skills**:

- Master's / Bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
- 8-13 years of experience in Statistical Programming in Clinical domain.
- Proven knowledge and training in high level computing languages such as SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
- Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
- In-depth knowledge of Good Clinical Practice, Clinical Research, Clinical trial process and related regulatory requirements and terminology.
- Good understanding of clinical drug development process.
- Strong communication skills and coordination skills. Ability to communicate with global teams with supervision.
- Detail-oriented and ability to learn and adapt to changes.
- Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint.

**The Application Process**:
**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.

**Key words**: Principal Statistical Programmer, Statistical Programmer, Statistical Programming, CRO, Contract Research Organisation

LI-SN1 #LI-REMOTE #Senior #FULLTIME

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