Associate Director Stat. Programmer

Role overview

Associate Director Stat. Programmer at Merck

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.

Responsibilities

• 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.

Employment details

• Location: Bangalore [Karnataka] [India]

Application details

• 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.

Additional role details

• 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.
• 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 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.