Job Description

Title:
Statistical Programmer I
Business Unit:
Global Clinical Development
Job Grade
Executive / G12A
Location:
Mumbai or Gurugram or Remote
Key Responsibilities
At Sun Pharma, we commit to helping you "Create your own sunshine"- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."
Position Summary:
The Statistical Programmer I will support one or more Phase I-IV studies programming activities as per the project strategies. The incumbent should be able to work in a team environment 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. The incumbent will work closely with PTL, team members and internal partnering functions to ensure all the programming deliverables are delivered in timely manner with high quality.
In this role, a typical day might include the following:

• Support 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 validate 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, TLFs specifications and macros updates.

• Contribute to 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.

• May need to support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with the team members.

• Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.

• Prioritize and manage the assignments and responsibilities on a need basis in a timely manner with high quality.

• Understand the scope of work, help to complete the deliveries and timelines working closely with the study team and programming lead.

• Performing end-to-end programming activities in a team environment.

This Role May Be For You If Have

• Good SAS programming skills in a clinical data environment with good analytical skills. Some knowledge of other programming languages such as R, Python etc. is a plus.

• Some basic knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions.

• Some working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Attention to detail, quick learner and able to adapt to a fast-paced environment.

• Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Having positive attitude, willingness to learn and explore, team player attitude and growth mindset.

• Problem solving and innovative skills that demonstrate initiative and motivation.

• Some demonstrated and applied SAS programming skills. SAS certificates a plus.

To Be Considered For This Opportunity You Must Have

• Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 1+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.

Travel Estimate
Low
Job Requirements
Educational Qualification
Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline
Experience
1+ years of programming experience in processing clinical trial data
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Skills Required