Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding Biostatistics Senior Associate (Study Statistician) – Amgen Discover more Knowledge Management Pharma Libraries Location Hyderabad, India Job Type Full-time (In office) Department Clinical – Global Biostatistics Experience Required 4+ years of post-graduate experience as a Statistician in Pharmaceutical, Biotechnology, Clinical Research, or Medical Research environments with a Master’s degree.

2+ years of post-graduate experience with a Doctoral degree in Statistics/Biostatistics.

Experience applying statistical methodologies in clinical trials is required.

Estimated Salary

Package (Market Standard) ₹18 – ₹35 LPA (approx.), depending on statistical expertise, clinical trial experience, programming skills, and interview performance.

Job Overview Discover more Jobs Academic Conferences & Publications statistical Statistical Data data Pharmacy The Biostatistics Senior Associate (Study Statistician) provides statistical expertise across clinical development programs by supporting study design, statistical analysis, clinical trial reporting, and regulatory submissions. The role involves authoring statistical documents, performing clinical trial analyses, ensuring data quality, and collaborating with cross-functional teams to deliver scientifically rigorous and compliant study outputs.

Key Responsibilities Statistical Study Support Provide statistical input throughout the clinical trial lifecycle.

Support study design, analysis planning, and interpretation of clinical data.

Conduct statistical analyses for

Primary endpoints

Secondary endpoints

Exploratory analyses

Dose-level evaluations

Ensure statistical methods are scientifically appropriate and aligned with regulatory expectations.

Statistical Documentation Author and review key statistical documents, including:

Statistical Analysis Plans (SAPs)

Table, Figure, and Listing (TFL) shells

Randomization specifications

Submission data file specifications

Statistical sections of clinical documents

Support preparation of clinical study reports and regulatory submission documents.

Clinical Data Analysis & Quality Control Perform statistical programming and data analysis using SAS or R.

Conduct quality control (QC) reviews of:

Clinical datasets

Statistical outputs

Analysis results

Ensure compliance with CDISC standards and data quality requirements.

Collaborate with Statistical Programmers for timely delivery of study outputs.

Cross-Functional Collaboration Participate in Clinical Study Team (CST) meetings.

Provide statistical guidance to clinical, data management, and programming teams.

Collaborate with external suppliers and review deliverable quality.

Support scientific publications and clinical research outputs. Regulatory & Compliance Activities Maintain statistical documentation within the Trial Master File (TMF).

Support audits and inspection readiness activities.

Follow Amgen SOPs, policies, and controlled documents.

Stay updated with regulatory guidelines and statistical methodologies.





Educational Qualification

Master's degree in

Statistics

Biostatistics

Mathematics

Or related fields with strong statistical content

OR Doctoral degree (PhD) in Statistics, Biostatistics, or related quantitative discipline.

Required Skills Solid understanding of statistical methods used in clinical trials.

Experience analyzing clinical trial data.

Proficiency in statistical programming

SAS

R

Knowledge of clinical development processes and drug development lifecycle.

Experience preparing statistical documentation.

Ability to interpret and communicate statistical findings.

Strong written and verbal English communication skills.

Ability to collaborate effectively with global teams.

Preferred Qualifications Master's degree with 6+ years of experience or Doctorate with 4+ years of experience.

Experience independently leading at least one clinical study or project.

Experience authoring

Protocols

Statistical Analysis Plans (SAPs)

Clinical Study Reports (CSRs)

Familiarity with CDISC standards

SDTM

ADaM

Experience using AI and automation tools for statistical efficiency.

Strong understanding of statistical applications across the clinical development lifecycle.

Work Environment On-site role based in Hyderabad.

Collaboration with global Biostatistics, Clinical Development, Data Management, and Statistical Programming teams.

Opportunity to support innovative biotechnology programs and global clinical trials.

Who Should Apply Study

Statisticians, Clinical Statisticians, Biostatisticians, and Statistical Analysts with pharmaceutical or clinical research experience.

Professionals with strong SAS/R skills and clinical trial expertise looking to advance in Clinical Biostatistics, Drug Development, Regulatory Statistics, and Global Research Programs.

Biostatistics Senior

Associate (Study Statistician) – Amgen Discover more Knowledge Management Pharma Libraries Location Hyderabad, India Job Type Full-time (On-site) Department Clinical – Global Biostatistics Experience Required 4+ years of post-graduate experience as a Statistician in Pharmaceutical, Biotechnology, Clinical Research, or Medical Research environments with a Master’s degree.

2+ years of post-graduate experience with a Doctoral degree in Statistics/Biostatistics.

Experience applying statistical methodologies in clinical trials is required.

Estimated Salary

Package (Market Standard) ₹18 – ₹35 LPA (approx.), depending on statistical expertise, clinical trial experience, programming skills, and interview performance.

Key Responsibilities Statistical Study Support Provide statistical input throughout the clinical trial lifecycle.

Support study design, analysis planning, and interpretation of clinical data.

Conduct statistical analyses for

Primary endpoints

Secondary endpoints

Exploratory analyses

Dose-level evaluations





Ensure statistical methods are scientifically appropriate and aligned with regulatory expectations.

Statistical Documentation Author and review key statistical documents, including:

Statistical Analysis Plans (SAPs)

Table, Figure, and Listing (TFL) shells

Randomization specifications

Submission data file specifications

Statistical sections of clinical documents

Support preparation of clinical study reports and regulatory submission documents.

Clinical Data Analysis & Quality Control Perform statistical programming and data analysis using SAS or R.

Conduct quality control (QC) reviews of:

Clinical datasets

Statistical outputs

Analysis results

Ensure compliance with CDISC standards and data quality requirements.

Collaborate with Statistical Programmers for timely delivery of study outputs.

Cross-Functional Collaboration Participate in Clinical Study Team (CST) meetings.

Provide statistical guidance to clinical, data management, and programming teams.

Collaborate with external suppliers and review deliverable quality.

Support scientific publications and clinical research outputs. Regulatory & Compliance Activities Maintain statistical documentation within the Trial Master File (TMF).

Support audits and inspection readiness activities.

Follow Amgen SOPs, policies, and controlled documents.

Stay updated with regulatory guidelines and statistical methodologies.

Educational Qualification

Master's degree in

Statistics

Biostatistics

Mathematics

Or related fields with strong statistical content

OR Doctoral degree (PhD) in Statistics, Biostatistics, or related quantitative discipline.

Required Skills Strong understanding of statistical methods used in clinical trials.

Experience analyzing clinical trial data.

Proficiency in statistical programming

SAS

R

Knowledge of clinical development processes and drug development lifecycle.

Experience preparing statistical documentation.

Ability to interpret and communicate statistical findings.

Strong written and verbal English communication skills.

Ability to collaborate effectively with global teams.

Preferred Qualifications Master's degree with 6+ years of experience or Doctorate with 4+ years of experience.

Experience independently leading at least one clinical study or project.

Experience authoring

Protocols

Statistical Analysis Plans (SAPs)

Clinical Study Reports (CSRs)

Familiarity with CDISC standards

SDTM

ADaM

Experience using AI and automation tools for statistical efficiency.

Strong understanding of statistical applications across the clinical development lifecycle.

Work Environment On-site role based in Hyderabad.

Collaboration with global Biostatistics, Clinical Development, Data Management, and Statistical Programming teams.

Opportunity to support innovative biotechnology programs and global clinical trials.

Who Should Apply Study

Statisticians, Clinical Statisticians, Biostatisticians, and Statistical Analysts with pharmaceutical or clinical research experience.

Professionals with strong SAS/R skills and clinical trial expertise looking to advance in Clinical Biostatistics, Drug Development, Regulatory Statistics, and Global Research Programs.

📌 Biostatistics Senior Associate (Study Statistician) – Amgen (Hyderabad)
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