Senior Manager, Biostatistics

Jobgether; India; Hybrid; INR 4,000,000 - 7,000,000; Full time

Benefits offered by this job

Remote/hybrid work

Global exposure

Professional growth

Learning & development

Healthcare & paid leave

Job summary

Jobgether, on behalf of a partner company, seeks a Senior Manager, Biostatistics based in India to lead statistical activities across global clinical development programs.

You will design, analyze, and interpret data for registration-directed trials, author SAPs, ADaMs, and TFLs, and support NDA/BLA submissions while collaborating with cross‑functional teams.

Qualifications

• PhD or equivalent with substantial biostatistics experience in clinical development.
• Strong command of statistical methods and their regulatory relevance.
• Experience supporting NDA/BLA submissions and eCTD is advantageous.

Responsibilities

• Serve as study biostatistician across development programs and multiple studies.
• Author SAPs, TFL shells and other statistical documents within timelines.
• Oversee ADaM specifications and generation of ADaMs and TFLs.
• Plan and implement analyses and contribute to clinical study reports.
• Provide statistical consultation to cross‑functional teams for decision making.
• Support regulatory submissions and interactions with health authorities.

Skills

SAS

R

Study design

Statistical analysis

Regulatory submissions

Education

PhD in Statistics/Biostatistics

Master's degree in related field

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 Senior Manager, Biostatistics based in India.

This is a senior biostatistics opportunity within global clinical development, supporting the design, execution, analysis, and interpretation of registration-directed clinical trials. You will serve as a study biostatistician across development programs and multiple studies, contributing statistical expertise throughout the clinical development lifecycle. The role combines hands‑on statistical analysis with strategic input into study design, regulatory submissions, and cross‑functional decision‑making. You will collaborate with clinical development teams and external partners while ensuring high‑quality deliverables and alignment with regulatory requirements and established procedures. The position also offers the opportunity to contribute to statistical methodology innovation, trial design simulations, process improvements, and the development of technical standards. Success requires strong technical expertise, independent judgment, attention to detail, and the ability to manage multiple priorities in a rapidly evolving environment. This remote/hybrid role is well suited to a motivated biostatistics leader who wants to make a meaningful impact on global clinical programs.

Accountabilities

• Study Biostatistics: Serve as the study biostatistician across development programs and multiple clinical studies, providing statistical expertise throughout the study lifecycle.
• Statistical Documentation: Author Statistical Analysis Plans (SAPs), TFL shells, and other study‑related statistical documents, ensuring they are scientifically sound, accurate, and delivered according to established timelines.
• ADaM & TFL Oversight: Review ADaM specifications, oversee the generation of ADaMs and Tables, Figures, and Listings (TFLs), and ensure timely, high‑quality statistical deliverables.
• Statistical Analysis: Plan and implement statistical analyses, contribute statistical content to clinical study reports, and perform statistical activities supporting regulatory submissions.
• Exploratory Analysis: Plan and execute exploratory analyses and provide statistical consultation to applicable cross‑functional teams to support clinical development decisions.
• Regulatory & Scientific Support: Provide statistical support for Health Authority requests, publications, presentations, posters, medical conferences, and symposia as assigned.
• Clinical Study Design: Contribute to innovative statistical methodologies and clinical trial designs, including performing simulations to evaluate alternative study design options and analytical approaches.
• Cross‑Functional Collaboration: Participate actively in study team and project team meetings, providing clear statistical guidance and helping teams make informed development decisions.
• Regulatory Compliance: Ensure statistical activities adhere to applicable regulatory requirements, departmental procedures, standards, and relevant SOPs.
• Process Improvement: Contribute to process improvement initiatives, SOP development, training activities, and efforts to strengthen statistical standards and technical capabilities.
• Team Contribution: Foster a collaborative, results‑oriented working environment through open communication, partnership, knowledge sharing, and objective decision‑making.

Requirements

• Education & Experience: PhD in Statistics, Biostatistics, or a related discipline with at least 5 years of relevant experience is preferred; a Master's degree combined with approximately 10 years of relevant experience is also considered.
• Clinical Development Knowledge: Strong understanding of drug development from Phase I through Phase IV, with the ability to apply biostatistical principles throughout the clinical development lifecycle.
• Statistical Expertise: Strong knowledge of statistical analysis principles, techniques, interpretation, and clinical relevance, with the ability to translate statistical findings into meaningful development insights.
• Programming Skills: Proficiency with statistical analysis software such as SAS and R.
• Regulatory Submission Experience: Experience supporting NDA/BLA submissions and eCTD submissions is an advantage.
• Therapeutic Area Experience: Experience in dermatology or oncology drug development is a plus.
• Analytical & Problem‑Solving Skills: Strong analytical thinking with the ability to identify issues, evaluate alternative approaches, conduct simulations, and develop effective statistical solutions.
• Project Management: Excellent organizational and time‑management skills, with the ability to coordinate multiple projects, manage competing priorities, and consistently meet established deadlines.
• Communication: Excellent written and verbal communication skills, with the ability to explain complex statistical concepts clearly and maintain effective dialogue with cross‑functional stakeholders.
• Quality & Attention to Detail: High level of accuracy and attention to detail, with a strong commitment to producing reliable, high‑quality statistical deliverables.
• Accountability: Strong ownership of responsibilities and outcomes, with an understanding of how individual decisions, results, and behaviors affect broader project and team performance.
• Collaboration: Team‑oriented approach with the ability to work cooperatively, champion strong ideas, support colleagues, and contribute to effective cross‑functional solutions.
• Independence: Comfortable working independently when required while remaining engaged and collaborative within broader project teams.
• Adaptability: Results‑driven, motivated, decisive, flexible, and creative, with the ability to thrive in a rapidly growing and changing environment.
• Strategic Mindset: Forward‑thinking approach with the ability to anticipate challenges, manage multiple priorities, and contribute to innovation in statistical methodology and clinical trial design.

Benefits

• Work Flexibility: Remote/hybrid working arrangement designed to provide flexibility while supporting collaboration across global clinical development teams.
• Professional Growth: Opportunities to expand technical expertise in biostatistics, clinical development, statistical methodology, trial design, and regulatory submissions.
• Learning & Development: Opportunities to contribute to training, technical capability building, SOP development, and continuous professional development.
• Global Exposure: Work across global clinical development programs and collaborate with cross‑functional teams and external resources.
• Career Impact: Opportunity to contribute directly to registration‑directed clinical trials, regulatory activities, scientific publications, and broader clinical development strategy.
• Collaborative Environment: Supportive, team‑oriented culture that values open communication, knowledge sharing, accountability, and professional growth.
• Well‑Being & Growth: Robust benefits and opportunities designed to support both personal well‑being and long‑term professional development.
• Additional Benefits: Salary, healthcare, paid leave, retirement benefits, and other employee perks may be provided according to the partner company's applicable policies.