Senior Principal Statistical Programmer

Merck KGaA, Darmstadt, Germany; Hyderabad; On-site; INR 1,500,000 - 2,900,000; Full time

Job summary

Merck KGaA in Hyderabad, India, seeks a Senior/Principal Statistical Programmer to lead programming activities across clinical trials. You will work within a matrix setup, coordinating datasets, analyses, and regulatory submission-ready outputs in line with CDISC standards.

The role requires 3–6+ years of pharma/clinical development experience, hands-on SDTM/ADaM expertise, and strong R skills. Collaboration across international teams and CRO oversight are key aspects of this position.

Qualifications

• Bachelor’s or Master’s in a numerate discipline; statistics, math or CS.
• 3–6+ years of directly relevant statistical programming in pharma/CRO.
• Hands-on SDTM/ADaM experience; integrated databases for submissions.
• Strong knowledge of regulatory guidance (ICH/FDA/EMEA).

Responsibilities

• Coordinate programming workstreams across trials and projects.
• Oversight of CRO activities to ensure timely delivery.
• Develop/validate SDTM/ADaM datasets and submission outputs.
• Contribute to standards, processes, and best practices in Biostatistics.

Skills

R programming

SDTM/ADaM

Statistical programming

Leadership

Regulatory knowledge

Education

Bachelor’s/Master’s in Statistics/Math/CS

Tools

R

Job description

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. Thats 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.

Your Role:

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 a Statistical Programmer at the Senior or Principal level, you will contribute to and lead statistical programming activities across one or more clinical trials and global project sub-tasks within clinical development programs. Working within a matrix organisation and under the oversight of a Project Statistical Programmer, you will coordinate programming workstreams, provide oversight of Contract Research Organisation (CRO) activities, and ensure the timely, accurate delivery of analysis datasets and outputs in line with regulatory standards. You will apply and deepen your expertise in CDISC SDTM and ADaM standards, contribute to integrated databases and submission-ready deliverables, and bring a proactive, solutions-oriented mindset 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 organisation’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 3 to 6+ years of directly relevant statistical programming experience within clinical development at a pharmaceutical, biopharmaceutical, or CRO environment.
• You have hands‑on experience working with SDTM datasets and creating ADaM datasets and specifications — and at the more senior level, integrated databases for regulatory submissions.
• You are proficient in R and demonstrate solid knowledge of ICH and CDISC SDTM and ADaM standards, with the ability to interpret and apply relevant regulatory guidance from ICH, FDA, and EMEA.
• 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 organisational, communication, and interpersonal skills and the ability to manage multiple priorities with accuracy and attention to detail.
• You demonstrate leadership capability — whether coordinating programming activities, guiding colleagues on processes and regulatory requirements, or driving project commitments with composure and clear decision‑making under pressure.

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!