Senior Manager, Statistical Programming

SUN PHARMA; Gurugram District; Hybrid; INR 3,500,000 - 5,500,000; Full time

Job summary

Sun Pharma is seeking a Senior Manager, Statistical Programming to lead and support all programming activities for multiple studies. The role requires delivering high-quality SDTM/ADaM datasets, creating CDISC specifications, and ensuring readiness for regulatory submissions.

You will mentor junior programmers, collaborate with global teams, and drive standards in CDISC implementations while advancing project timelines and quality.

Qualifications

• Minimum 10+ years of programming experience processing clinical trial data.
• Experience in biotechnology, pharmaceutical, CRO or health care industries.
• Proficiency in SAS programming in a clinical data environment with strong analytical skills.
• Experience with CDISC standards and regulatory submissions.

Responsibilities

• Lead programming activities for trials and studies with timely, high-quality deliverables.
• Develop and maintain SAS programs for SDTM and ADaM datasets and reports.
• Create CDISC SDTM mapping specifications and ADaM specifications.
• Mentor and coach junior programmers.
• Support regulatory submissions to health authorities.

Skills

SAS programming

R

Python

CDISC standards

SDTM mapping

ADaM specs

Statistical programming

Regulatory submissions

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline

Job description

Title: Senior Manager , Statistical Programming

Business Unit: Global Clinical Development

Job Grade: G9

Location: Remote/Hybrid

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.

Job Description

The Senior Manager 2 will provide comprehensive programming expertise to lead and support all programming activities as per the project strategies. The incumbent should be able to 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. The incumbent will work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in timely manner with high quality. The incumbent will participate in and contribute to department goals, SOPs, macros, SME topics and act as a technical expertise to provide guidelines on CDISC standards.

In this role, a typical day might include the following:

• 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 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.
• Participate and contribute towards department goals, SOPs, training guidelines and SME topics.
• Mentor and Coach new hires and junior programmers.

This Role May Be For You If You Have

• Proficiency in 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.
• Excellent knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).
• Excellent working knowledge of implementing CDISC standards, Regulatory guidance and TAUG.
• 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.
• Hands-on programming as well as people and process management experience.
• Demonstrated and applied SAS programming skills. SAS certificates a plus.

Educational Qualification

Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.

Experience: 10+ years of programming experience in processing clinical trial data

in the biotechnology, pharmaceutical, CRO or health care related industry.

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).