Statistical Programmer II

1 month ago

Chennai, Tamil Nadu, India Allucent Full time
Unlock Your Potential as a Statistical Programmer II at Allucent

At Allucent, we're dedicated to empowering small-medium biopharmaceutical companies to navigate the complex world of clinical trials and bring life-changing therapies to patients worldwide.

We're seeking a highly skilled Statistical Programmer II to join our team. As a key member of our A-team, you'll play a vital role in supporting the programming of clinical data analysis activities. This is an exciting opportunity to work on multiple studies, develop simple to moderate datasets, and create outputs using SAS, while beginning to control and monitor specific activities within the project team.

Key Responsibilities:
  • Support the programming of clinical data analyses.
  • Create and execute SAS programs according to project specifications for simple outputs, including data listings.
  • Implement statistical analysis plans.
  • Understand and comply with all industry-relevant regulatory requirements.
  • Employ standardized programs where applicable.
  • Validate the work of other programmers.
  • Ensure the maintenance of programming documentation, including descriptions of programs and validation.
  • Interact with statisticians, data management personnel, and project leaders.
  • Analyze and evaluate clinical data, recognizing inconsistencies and initiating resolution of data problems.
  • Create and execute SAS programs according to project specifications for mapped datasets, including SDTM.
  • Support projects and execute statistical programming activities according to timelines and milestones, ensuring quality and efficiency.
  • Generate aCRF, define XML, and other study documents.
  • Familiarity with Pinnacle 21, managing delivery QC checklists, large study batching, checking logs, and other project management processes necessary to lead a study.
  • Familiarity with CDISC standards and writing SDTM specs for studies with simple complexity.
  • Create and/or review SDTM and/or mapped data specifications of simple complexity.
  • Actively participate in staff learning and development within the company.
  • Ability to provide mentoring to junior staff.
  • Understand and complete all SOPs within the Quality Management System on time.
  • Assure good communication and professionalism in relationships with clients.
  • Contribute to client evaluations, visits, and bid defences.
Requirements:
  • Statistics, mathematics, life science, healthcare, and/or business degree.
  • Good knowledge of computer systems, applications, and operating systems.
  • Good analytical skills.
  • Minimum 2-5 years of relevant work experience.
  • Minimum 2-5 years of experience in drug development and/or clinical research.
  • Ability to simplify complex issues into understandable concepts.
  • GDPR/HIPPA, CFR/CTR/CTD, and applicable (local) regulatory requirements.
  • Strong written and verbal communication skills, including a good command of the English language.
  • Proficiency with various computer applications, such as Word, Excel, and PowerPoint.
  • Advanced knowledge of SAS/Base, especially macros, arrays, formats, and ODS.
  • Good knowledge of SAS.
  • Representative, outgoing, and client-focused.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • Familiarity with basic statistical principles to interact with biostatisticians.
Benefits:
  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our enriching Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.

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