Job Description

Grade: Manager

Location: Hybrid at Gurugram/Mumbai. 100% Remote for the right candidate.

Job Purpose

• Lead one or more Phase I-IV studies programming activities as per the project strategies.
• Work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.
• Work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in a timely manner with high quality.
• Participate in and contribute to development of standard macros, libraries, processes and act as a team player on the various programming tasks.

Key Roles and Responsibilities

• Lead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables in assigned projects and areas.
• Develop and maintain programming documentations following programming standards and processes. Create CDISC standard SDTM mapping specifications and ADaM specifications.
• Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).
• Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.
• Participate in the CRF annotation, review of SAP, TLFs specifications development and TLFs review.
• Handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for the regulatory submission to FDA/EMA/PMDA or other agencies.
• Support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.
• Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.
• Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.
• Performing end-to-end programming activities, act as a team player and SME.
• Focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.
• Ensure all work is completed adhering to the internal SOPs where applicable.
• Mentor and Coach new hires and junior programmers. Require good collaborative skills.

Qualification, Skill and Competencies Requirements

• Minimum Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.
• Oncology Therapeutic area preferred.
• Strong SAS programming skills in a clinical data environment with excellent analytical skills. Working knowledge of other programming languages such as R, Python etc. is a plus.
• Great knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).
• Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Prior PTL experience, attention to detail and able to adapt to a fast-paced environment.
• Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset.
• Problem solving and innovative skills that demonstrate initiative and motivation.
• Demonstrated and applied SAS programming skills. SAS certificates a plus.