Associate Director Stat. Programmer

Merck Healthcare; Bengaluru; On-site; INR 2,000,000 - 3,500,000; Full time

Job summary

Merck Healthcare is seeking an Associate Director, Statistical Programmer in Bengaluru/Hyderabad. You will lead statistical programming activities across trials and global projects, ensuring timely, regulator-ready outputs and datasets.

You will coordinate CRO work, apply CDISC SDTM and ADaM standards, and contribute to best practices within the Global Biostatistics function. Strong collaboration and regulatory submission experience are essential.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, or Computer Science.
• 10+ years of directly relevant statistical programming experience in clinical development.
• Based in Bangalore or Hyderabad with ability to work in a matrix, global teams.

Responsibilities

• Lead statistical programming activities across trials and global projects.
• Coordinate CRO work and ensure timely delivery of analysis datasets and outputs.
• Apply CDISC SDTM and ADaM standards for regulatory submissions.
• Share knowledge and contribute to programming standards within Biostatistics.

Skills

R

Statistical programming

CDISC SDTM/ADaM

Education

Numerate degree (BSc/MSc)

Tools

R

Job description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Statistical programming sits at the heart of clinical evidence generation — and in this role, you will be instrumental in turning complex data into the high-quality deliverables that advance medicines from development to patients. As an Associate Director, Statistical Programmer, you will contribute to and lead statistical programming activities across one or more clinical trials and global projects within clinical drug development programs.

Working in a matrix organization, either under the oversight of a Project Statistical Programmer or serving in that role yourself, you will provide functional leadership for programming activities, coordinate and oversee work performed by CRO partners and internal programmers and ensure the timely and accurate delivery of analysis datasets and outputs in accordance with regulatory standards. As an individual contributor, you will make an impact through your technical expertise, project leadership, and collaboration across teams.

You will apply and further develop your expertise in CDISC SDTM and ADaM standards, contribute to integrated databases and submission-ready deliverables, and take a proactive, solutions-oriented approach to complex technical and operational challenges.

Beyond project delivery, you will play an active role in advancing best practices and process improvements within the Global Biostatistics function — sharing knowledge, guiding colleagues, and helping to shape the programming standards that underpin the organization’s clinical pipeline.

Who You Are

• You hold a Bachelor’s or Master’s degree in a numerate discipline — such as Statistics, Mathematics, or Computer Science — or equivalent professional experience.


• You bring 10+ years of directly relevant statistical programming experience within clinical development at a pharmaceutical, biopharmaceutical, or CRO environment.


• The position is based in Bangalore or Hyderabad.


• You are highly proficient in R and demonstrate solid knowledge of ICH guidelines and CDISC SDTM and ADaM standards, with the ability to interpret and apply relevant regulatory guidance from ICH, FDA, and EMA.


• You have hands-on experience working with SDTM datasets, developing ADaM datasets and specifications, and contributing to integrated databases such as ISS and ISE for regulatory submissions.


• You have a sound understanding of drug development processes and the interfaces between statistical programming and other clinical development functions, including familiarity with relevant therapeutic areas and regulatory submission requirements.


• You work effectively in international, multicultural, and cross-functional matrix teams, with strong organizational, communication, and interpersonal skills and the ability to manage multiple priorities with accuracy and attention to detail.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!