Manager Biostatistics (Study Lead Statistician) Job at Amgen (Hyderabad)

Senior Manager Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

New

Biostatistical Programming Manager

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 6 years of statistical programming experience in clinical development environment
Thorough understanding of clinical trial processes, from data collection to analysis reporting
Proven record of superior statistical programming and problem-solving skills within clinical development environment
Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities for a study end-to-end
In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
Advanced analysis and reporting skills in SAS, including SAS/STAT packages
Experience in data quality and compliance check tools
Excellent project management skills and ability to lead multiple projects effectively
Excellent oral and written English communication skills
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
Lead and manage specific programming tasks assigned to the team
Participate in establishing the programming scope for a deliverable with the statisticians and the study team
Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
Create and maintain programming related specifications for the studies/projects
Represent GSP at the Clinical Study Team
Attend meetings for, and provide programming input into, cross-functional study start-up activities
Initiate cross-functional team meetings as necessary
Perform significant hands-on statistical programming, particularly for those most challenging deliverables

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Biostatistical Programming Manager

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 6 years of statistical programming experience in clinical development environment
Thorough understanding of clinical trial processes, from data collection to analysis reporting
Proven record of superior statistical programming and problem-solving skills within clinical development environment
Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end
In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others
Experience in data quality and compliance check tools
Excellent project management skills and ability to lead multiple projects effectively
Excellent oral and written English communication skills
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team
Participate in establishing the programming scope for a deliverable with the statisticians and the study team
Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects
Represent GSP at the Clinical Study Team (CST)
Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
Initiate cross-functional team meetings as necessary
Perform significant hands-on statistical programming, particularly for those most challenging deliverables

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Vice President, Biostatistics

The Vice President, Biostatistics is a key enterprise leader responsible for set...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

PhD or Master’s degree in Biostatistics, Statistics, or related field
10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs
At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups
Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions
Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams
Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred
Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness
Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences
Experience managing departmental budgets, vendor relationships, and technical infrastructure
Highly collaborative, with strong interpersonal skills and the ability to build trust across teams

Job Responsibility

Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture
Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio
Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making
Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success
Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings
Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning
Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies
Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation
Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making
Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials

What we offer

health and retirement
PTO
stock option plans

New

Principal Statistical Programmer

As a member of Parexel’s Statistical Programming group, you analyze, summarize, ...

Location

United States , Newton, Massachusetts

Salary:

159896.21 - 207400.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's in Statistics, Mathematics, Pharmaceutical Science, Data Analytics or related field. Employer will accept post-secondary academic coursework and/or relevant work experience which is evaluated as equivalent to a U.S. Bachelor’s degree in accordance with 8 CFR § 214.2(h)(4)(iii)(D)
7 years of progressive experience in statistical programming
7 years of experience with: Programming and reporting process
FDA 21 CFR Part 11 regulations
Regulatory requirements (ICH-GCP, CDISC, and electronic submissions)
Analyzing data from Phase I, II, and III clinical trials
SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Step, Proc Step, and Functions
Generating reports, tables, and listings for statisticians
Building structured, CDISC, SDTM, or ADaM databases for clinical studies
Leading teams in a statistical programming environment

Job Responsibility

Provide technical support and expert advice to internal and external sponsors on statistical programming projects to support clinical trial activities
Work independently to support various programming activities related to analysis and reporting of clinical study data
Fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas
Monitor quality, timelines, resource allocation, and productivity in relation to budget
Project management for statistical programming
Advise and negotiate statistical programming timelines

What we offer

Employee Referral Program
Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Sr. Manager/AD, Statistical Programmer

Beam is looking for an associate Director/Director of statistical programming to...

Location

United States , Cambridge

Salary:

155000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MS or higher degree in Statistics, Mathematics, or related scientific Discipline
At least 12 years Pharmaceutical/Biotech programming experience
Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies
NDA or BLA submission experience is required
Excellent organizational skills and ability to prioritize tasks
Excellent communication and interpersonal skills
Experience managing CROs and other data vendors
Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance

Job Responsibility

Lead and manage statistical programming activities on clinical studies and oversee CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions
Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs
Work collaboratively and communicate effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions
Manage creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources
Manage the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R
Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures
Partner with Statisticians and other members of the clinical study team, perform ad hoc analysis
Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs and provide expert feedback from functional perspective
Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities
Assist the Head of Statistical Programming to develop and implement programming processes, programming standards and SOPs

Fulltime

Associate director, biostatistics

The Associate Director, Oncology Biometrics is a skilled biostatistician who can...

Location

United States , Bothell; La Jolla; Cambridge; Groton; New York City

Salary:

139100.00 - 225100.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a master’s degree in Statistics, Biostatistics or related field with 7+ years of experience in clinical trials
Demonstrated high aptitude in FDA/EMA and other regulations
Demonstrated high aptitude in ICH GCP guidelines
Demonstrated high aptitude in Drug development process
Demonstrated high aptitude in CDISC standards and implementation guides
Demonstrated high aptitude in Statistical methods and applications to clinical trial design and data analysis
Demonstrated high aptitude in Programming skills in R and/or SAS
Demonstrated high aptitude in Company SOPs and business practices
Demonstrated ability to develop and deliver multi-mode communications
Demonstrated ability to manage multiple projects

Job Responsibility

Serve as a study statistician for assigned clinical studies related to one or more clinical programs
Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner
Provide statistical inputs on clinical development plans
Contribute to the development of clinical study protocols and author the statistical sections
Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses
Develop study randomization specification and verification documents as necessary
Perform sample size calculations and assess trial design operating characteristics under various assumptions
Review CRFs and edit checks and participate in UAT of different systems
Review dataset programming specifications, key derived variables, and statistical deliverables
Independently derive from source data key efficacy variables and analyses

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Associate Director, Statistical Programming

This is a critical role responsible for leading statistical programming activiti...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of relevant experience with MS
5+ years of relevant experience with PhD
Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support
Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
Expertise in SAS programming and comprehensive knowledge of CDISC standards
Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field

Job Responsibility

Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
Conduct independent validation and quality checks of statistical programming deliverables from CROs
Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime

Manager Biostatistics (Study Lead Statistician)

Amgen

Location:
India , Hyderabad

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 16, 2026

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