Associate Director, Biostatistics

Jobgether; India; Hybrid; INR 3,500,000 - 6,000,000; Full time

Benefits offered by this job

Remote or hybrid options in India

Global clinical development exposure

Senior-level cross-functional exposure

Professional development

Job summary

Jobgether seeks an Associate Director, Biostatistics based in India to lead statistical efforts across global clinical programs. You will influence trial design, analysis, and regulatory submissions from Phase I to IV, while ensuring quality and timely delivery.

The role emphasizes expertise in SAS/R, ADaM/TFLs, and collaboration with internal and external partners in a fast-paced pharmaceutical R&D environment.

Qualifications

• Ph.D. or M.S. in Biostatistics, Statistics, or related field.
• Extensive industry experience in pharmaceutical R&D and regulatory submissions.

Responsibilities

• Provide statistical leadership across development programs and studies.
• Author analysis plans, ADaM specs, TFLs, and regulatory documents.
• Review data standards (ADaM, TFLs) and ensure quality and timeliness.
• Support NDA/BLA submissions and regulatory authority responses.
• Contribute to study design, simulations, and methodological improvements.
• Collaborate with cross-functional teams across global programs.

Skills

Biostatistics leadership

Clinical trial design

SAS and R

Regulatory submissions

Cross-functional collaboration

Scientific communication

Education

Ph.D. in Biostatistics/Statistics

M.S. in Biostatistics/Statistics

Tools

SAS

R

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director, Biostatistics based in India.

This role offers an opportunity to provide senior biostatistical leadership across global clinical development programs and registration-directed studies.
You will contribute to clinical trial design, statistical analysis, interpretation, and regulatory submissions from Phase I through Phase IV.
Working across multidisciplinary teams, you will translate complex statistical questions into clear, scientifically sound recommendations.
You will own key statistical deliverables while ensuring quality, regulatory compliance, and timely execution.
The role combines hands‑on statistical expertise with opportunities to influence methodology, trial design, standards, and process improvement.
You will collaborate with internal stakeholders and external partners in a dynamic pharmaceutical R&D environment.
Success requires scientific rigor, strong communication, accountability, and the ability to manage multiple priorities independently.

Accountabilities

• Serve as the study biostatistician across development programs and multiple clinical studies, providing statistical leadership throughout the study lifecycle.

• Author statistical analysis plans, TFL shells, and other study‑specific statistical documentation.

• Review ADaM specifications, oversee the generation of ADaMs and TFLs, and ensure accurate, high‑quality, and timely deliverables.

• Plan and execute statistical analyses and provide statistical input into clinical study reports and registration‑related activities.

• Conduct exploratory analyses and provide statistical consultation to cross‑functional clinical development teams.

• Support responses to Health Authority requests and contribute to scientific publications, presentations, posters, and medical conference materials.

• Provide statistical expertise for clinical trial design, including simulations to evaluate alternative study designs and analytical approaches.

• Contribute statistical perspectives during cross‑functional study team and project team meetings.

• Support innovation in statistical methodology, trial design, standards, and analytical processes.

• Participate in process improvement initiatives, SOP development, training, and activities designed to strengthen statistical capabilities.

• Ensure adherence to departmental procedures, company standards, and applicable regulatory requirements.

• Build productive relationships across functions, promote teamwork, communicate openly, and contribute to a positive, results‑oriented working environment.

Requirements

• Ph.D. or M.S. in Biostatistics, Statistics, or a closely related quantitative discipline.

• At least 10+ years of industry experience in pharmaceutical R&D for Ph.D. holders, or 15+ years for M.S. holders, or equivalent relevant experience.

• Demonstrated understanding of drug development from Phase I through Phase IV.

• Strong knowledge of statistical principles, analytical techniques, interpretation, and clinical relevance.

• Proficiency with statistical programming and analysis tools, particularly SAS and R.

• Experience supporting global clinical development programs and registration‑directed clinical trials.

• Strong understanding of statistical documentation, analysis plans, clinical study reports, ADaM, TFLs, and regulatory submission activities.

• Ability to contribute to statistical methodology, trial design, simulations, and exploratory analyses.

• NDA/BLA and eCTD submission experience is an advantage.

• Experience in dermatology or oncology drug development is a plus.

• Excellent organizational and time‑management skills, with the ability to manage multiple projects and meet demanding deadlines.

• Strong written and verbal communication skills, with the ability to explain statistical concepts clearly to technical and non‑technical stakeholders.

• Exceptional attention to detail and commitment to data quality and scientific rigor.

• Strong ownership and accountability for outcomes, with the ability to work independently while contributing effectively within collaborative teams.

• Forward‑thinking, flexible, decisive, and creative approach to solving complex problems in a rapidly evolving environment.

• Ability to identify risks, resolve issues, prioritize competing demands, and maintain high‑quality execution.

• Experience working within a growing or publicly traded pharmaceutical organization is advantageous.

Benefits

• Remote or hybrid working options in India.

• Opportunity to contribute to global clinical development programs and registration‑directed studies.

• Senior‑level exposure to multidisciplinary teams spanning clinical development, regulatory, and scientific functions.

• Opportunities to influence statistical methodology, clinical trial design, standards, and process improvement.

• Professional development and opportunities to expand technical and leadership expertise.

• Collaborative environment focused on continuous improvement, teamwork, and scientific excellence.

• Comprehensive employee benefits supporting health, well‑being, and professional growth.

• Opportunity to make a meaningful impact on innovative pharmaceutical R&D programs.

• Supportive environment designed to encourage ownership, collaboration, and long‑term career development.