Associate Director, Clinical Data Scientist - Statistics

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; On-site; INR 4,000,000 - 9,000,000; Full time

Benefits offered by this job

Competitive Salary + Bonus

Hybrid work environment

Healthcare & Life Insurance

Learning & Development programs

Job summary

Takeda Innovations India Private Limited seeks an Associate Director-level clinical data science leader to translate complex clinical and biomarker data into actionable evidence guiding development decisions. Lead advanced analytics, apply AI/ML, and ensure submission-ready data and insights across studies.

Collaborate with Clinical, Regulatory, PSPV, Translational Sciences, and other partners to ensure high-quality, governance-aligned analytics.

Qualifications

• PhD or MS with extensive clinical data science experience.
• Experience in regulated clinical development and cross-functional influence.
• Hands-on leadership, vendor oversight, and mentorship capabilities.

Responsibilities

• Design and execute quantitative analyses across clinical data, biomarkers, and external data.
• Apply statistical/machine learning/simulation methods for patient-level predictions and risk assessment.
• Oversee end-to-end data analyses: design, cleaning, execution, reporting, and documentation.
• Mentor junior colleagues and delivery partners in analytic methods and reproducible workflows.
• Drive AI-enabled workflow improvements and governance of data standards.

Skills

Clinical trial design

Statistics

AI/ML

SAS

R/Python

SQL

CDISC SDTM/ADaM

Regulatory knowledge

Unx/ HPC basics

Education

PhD in statistics/biostatistics/data science

MS in statistics/biostatistics/Data science

Tools

SAS

R

Python

SQL

UNIX

Job description

Job Description Objective / Purpose

Serve as an Associate Director-level clinical data science leader within Data & Quantitative Sciences, translating complex clinical, biomarker, and external data into actionable evidence that informs clinical development decisions. Lead fit-for-purpose statistical, data science, and advanced analytics approaches across assigned studies, assets, or specialty areas, including exploratory analysis, predictive modeling, simulation, and integrated data review. Partner cross-functionally with Clinical, Clinical Pharmacology, PSPV, Clinical Data Management, Translational Sciences, Regulatory, Clinical Operations, and external partners to ensure high-quality, traceable, analysis and submission-ready data and decision-ready insights. Advance modern ways of working by applying AI/ML, automation, reusable analytics workflows, and governed data standards while maintaining scientific rigor, regulatory awareness, and patient-focused decision making.

Accountabilities

Design and/or execute quantitative analyses using clinical trial data, biomarkers, real-world data, external data, and other relevant sources to generate interpretable insights for study teams and governance forums. Apply appropriate statistical, machine learning, simulation, and visualization methods to support patient-level prediction, endpoint interpretation, risk assessment, scenario planning, and evidence generation. Perform end-to-end data analyses, from hypotheses formulation, experimental design, writing analysis plans, data cleaning, executing analysis, and preparing reports and documentation. Provide or identify internal and external statistical expertise and capacity to support development activities. Lead clinical data science strategy and delivery for one or more studies, assets, or capability areas, ensuring alignment with development objectives, timelines, quality expectations, and stakeholder needs. Provide scientific and technical oversight of internal and external delivery partners, including review of analysis plans, specifications, code, outputs, data visualization, and interpretation of findings. Identify, communicate, and mitigate risks related to data quality, analytic assumptions, vendor delivery, timelines, reproducibility, and regulatory acceptability of data science outputs. Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. Partner with Clinical Pharmacology PSPV, Translational Sciences, Clinical Data Management, Regulatory, and platform teams to ensure that CDISC, submission, and downstream quantitative decision-making needs are built into study setup, data review, and reporting processes. Define requirements for model-ready datasets and analytics-ready data flows, including variable derivations, data quality expectations, lineage, traceability, metadata, and documentation sufficient for regulated clinical development use. Mentor junior colleagues or delivery partners in clinical data science methods, reproducible analytic practices, technical problem solving, and effective communication of quantitative insights. Increase the external recognition of Takeda’s data science work by participating in conferences, publishing work and developing external collaborations. Drive continuous improvement in clinical data science practices through reusable code, standards, training, mentoring, automation, AI-enabled workflow improvements, and adoption of industry best practices.

Education & Competencies (Technical and Behavioral)

Education / Experience PhD in statistics, biostatistics, data science, applied mathematics, physics, epidemiology, biomedical engineering, computer science, quantitative sciences, or related field with 5+ years of relevant experience; or MS with 8+ years of relevant experience. Equivalent combinations should be reviewed with HR. Significant experience in clinical development within the pharmaceutical, biotechnology, or healthcare research environment, with demonstrated ability to influence cross-functional decisions at study, asset, or functional level. Experience providing technical leadership, matrix leadership, vendor oversight, and/or mentorship of junior colleagues or delivery partners.

Highest-priority Technical Skills

Advanced knowledge of clinical trial design, drug development, endpoints, estimands, biomarkers, data interpretation, and the role of analytics in clinical decision making. Strong foundation in statistics and quantitative methods, including longitudinal analysis, survival methods, causal reasoning, simulation, predictive modeling, and uncertainty communication. Experience integrating and interpreting diverse data sources, including clinical trial, biomarker, real-world, external, imaging, digital health, or other high-dimensional data as appropriate to the portfolio. Practical understanding of AI/ML and advanced analytics in regulated clinical development, including model development, validation, documentation, bias/assumption assessment, and fit-for-purpose deployment. Hands-on proficiency in SAS, with working knowledge of R and/or Python and SQL; ability to review and guide reproducible analyses, code quality, version control, and validated workflows. Ability to work independently on complicated datasets, including all aspects of data analysis (data cleaning, algorithm development, statistical analysis, and documentation). Working knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, Define-XML concepts, and submission-oriented data expectations. Knowledge of FDA, EMA, ICH-GCP, GxP, data privacy, inspection readiness, and traceability expectations relevant to clinical data and quantitative deliverables. A working knowledge of UNIX operating systems is preferred, ideally with experience in high-performance computing environments.

Behavioral Competencies

Communicates complex quantitative findings clearly to scientific, operational, technical, and senior leadership audiences. Influences across functions without relying on direct authority; builds trusted partnerships with clinical, statistical, programming, data management, regulatory, technology, and vendor stakeholders. Balances scientific rigor, speed, quality, and pragmatic delivery; proactively escalates risks with options and recommendations. Demonstrates enterprise mindset, curiosity, continuous improvement, and commitment to developing others and advancing modern clinical data science capabilities.

Benefits

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary + Performance Annual Bonus
• Flexible work environment, including hybrid working
• Comprehensive Healthcare Insurance Plans for self, spouse, and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs including annual health screening, weekly health sessions for employees.
• Employee Assistance Program
• 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity, Equity, and Inclusion Programs
• No Meeting Days
• Reimbursements – Home Internet & Mobile Phone
• Employee Referral Program
• Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)

About ICC in Takeda

Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day. As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

Locations

IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time

IND - Bengaluru - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.