Senior Manager Biostatistics Job at Amgen (Hyderabad)

Senior Manager, Statistical Programming

Beam is looking for a highly talented and motivated Senior Manager, Statistical ...

Location

United States , Cambridge

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MS or higher degree in Statistics, Mathematics, or related scientific Discipline
At least 10 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

Participates in statistical programming activities on clinical studies and oversees CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions
Reviews and validates SDTM, ADaM analysis datasets and TFLs created by CROs
Works collaboratively and communicates effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions
Manages creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources
Manages 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
Participates and manages the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures
Partners with Statisticians and other members of the clinical study team, performs ad hoc analysis
Reviews SAP, DMP, CRF, annotated CRF, table shells and other relevant documents by CROs and provides expert feedback from functional perspective
Develops SAS programming infrastructure and programming processes improve data deliverables and ad hoc analyses quality and efficiency
Builds and mentors a team of programmers as needed to support Beam clinical trials and development pipelines

Fulltime

Director of Data Management & Biometrics

This is a senior leadership role, responsible for shaping and delivering the str...

Location

United Kingdom

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Advanced degree in Statistics, Biostatistics, Computer Science, Life Sciences, or related discipline
MSc/PhD preferred
Significant leadership experience in clinical data management and biostatistics within a biopharmaceutical or CRO environment
Proven track record of building and managing high?performing biometrics teams through multiple phases of clinical development
Deep knowledge of CDISC standards (SDTM, ADaM), regulatory expectations, and EDC/CTMS environments
Demonstrated experience with advanced analytics, data standards, and clinical database design
Exceptional communicator with the ability to collaborate across functions, present to senior leadership, and engage external partners.

Job Responsibility

Lead and develop the Data Management & Biometrics function, including Clinical Data Management (CDM), Biostatistics, Statistical Programming, and medical coding standards
Own the design and delivery of data strategies that ensure high data quality, integrity and compliance throughout clinical development
Oversee development and implementation of data standards, CRF design, data flow plans, and database build/validation strategies
Partner with Clinical Operations, Safety, Regulatory, and IT to implement leading?edge technologies (e.g., EDC, eCOA, RTSM, CDISC standards)
Drive statistical analysis planning, statistical methods, and interpretation of complex clinical datasets
Ensure delivery of high-quality, timely outputs for interim looks, IDMC reporting, regulatory submissions, and final study reports
Represent Data Management & Biometrics in leadership forums, influencing cross-functional decision-making and resource prioritisation.

Fulltime

Senior Manager-Safety 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

MSc or PhD in Statistics, Biostatistics, or related field
Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience
Proven ability to apply statistical methods in clinical development
Proficient in an analytical application (e.g., R or SAS)

Job Responsibility

Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide sound statistical guidance for safety assessment
Act as an independent statistician, providing objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions and recommendations
Provide safety statistics expertise on aggregated safety analysis plans (ASAP) and safety assessment and reporting activities across multiple studies/products
Develop, maintain, and set standards for associated controlled process documents, including defining best practices for aggregate safety statistical methodologies, and support the development and application of related training and guidance materials across programs
Support innovative projects related to technical enhancements for safety assessment, involving data visualizations, decision-making toolkits, and appropriate advanced analytics, including AI integration
Maintain familiarity with Amgen statistical policies, strategies, and regulatory guidance, and stay abreast of developments in statistical methods relevant to safety assessment and reporting

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Vice president global head of statistics vcrd

Pfizer is seeking a Vice President, Global Head of Statistics to join our thrivi...

Location

United States , Pearl River; Collegeville

Salary:

274000.00 - 426800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree in statistics, biostatistics, or related field required. PhD preferred.
15+ years of experience in drug development
5-10 years of experience in vaccine development
At least 5 years of managerial experience in drug development
Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences
Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
A compelling and inspiring leadership style with a sharp scientific mind, who combines broad knowledge and understanding of biological systems and statistics. A world-class leader in his/her field.
Ability to perform sophisticated mathematical and statistical calculations, and to perform complex data analysis
Disaggregates complex problems to facilitate problem solving
Adept at distinguishing the relevance of information inputs to the decision-making process

Job Responsibility

Sets the vision and leadership for providing the highest level of data management, modeling, and statistical advice across the function to senior Vaccines Research and Development (VRD) leadership
Is accountable to lead the necessary stakeholders to plan, direct and coordinate a large and expanding portfolio of specialized and complex Vaccine Research and Development (VRD) projects spanning phase 1 through phase 4 clinical development
Must have the broadest knowledge of clinical data management and statistical analysis tools and interpret results from clinical, non-clinical, modelling and simulation, and epidemiologic studies
Is accountable to develop and roll out new initiatives and lead the VCRD Statistics group in strategic planning
Leads the activities of Senior Directors directing the statisticians and modelers in VCRD and at Functional Service Providers
Provides senior management review of protocols and CSRs, and is the senior representative to internal review committees, DMC-related company steering committees, etc.
Influences cross functional (TA) activities, in a consultative role, and provides the SVP of Clinical Research with more strategic advice as to the present and future direction for the VCRD Statistics group
Provides the highest level of strategic and statistic leadership to VRD leadership and the full vaccine portfolio
Lead and inspire the VRD statistics organization to provide the highest level of statistical and modeling support. Evaluates the material generated by supervised staff including senior director reports for validity, quality, and effectiveness of presentation and coaches them in preparation for regulatory and Key Opinion Leader interactions.
Provide senior management statistical review of key documents (protocols, CSRs, regulatory briefings)

What we offer

eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% 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 support available

Fulltime

Biostatistical Programming Senior Manager

In this vital role you will be responsible for developing and leading teams in t...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Master’s degree and 8 to 10 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Bachelor’s degree and 10 to 14 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Diploma and 14 to 18 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least eight (8) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a statistical programming team working with real-world healthcare data (RWD)
Experience leading a statistical programming team within RWE
RWE generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
Department or multi-team management

Job Responsibility

Provide technical solutions to programming problems within the Centre for Observational Research (CfOR)
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Project manage programming activities, according to agreed resource and timeline plans
Ensure programming activities adhere to departmental standards and SOPs
Write and/or review and approve programming plans
Write and/or review and approve analysis dataset specifications
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
Write, test, validate and execute department-, product- and protocol-level macros and utilities

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Oncology Early-Stage Clinical Scientist

You will lead and coordinate the development of multiple studies of novel biolog...

Location

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

Salary:

176600.00 - 282900.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO
MS and a minimum of 7 years of experience in a similar role in industry/CRO
BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
Experience in or strong understanding of Oncology Drug Development especially in Early Development
Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Strong scientific writing skills and communication skills (written and verbal)
Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance

Job Responsibility

Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
Support execution for all FIH programs through proof-of concept
Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends
review and query data
present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials

What we offer

Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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 – Value Communication and Evidence Synthesis

As Associate Director – Value Communication & Evidence Synthesis, you will play ...

Location

United Kingdom

Salary:

Not provided

Bioscript Group

Expiration Date

Until further notice

Requirements

Postgraduate degree (MSc or PhD) in Health Economics, Public Health, Epidemiology, Biostatistics, or related life sciences discipline
7+ years in market access, value communication, HEOR, or HTA consulting, with proven ability to lead complex, multi-disciplinary projects
Deep understanding of global HTA processes, payer evidence requirements, and market access dynamics
Demonstrated experience in evidence generation and synthesis, including systematic literature reviews, indirect treatment comparisons, and meta-analyses
Excellent analytical and writing skills, with the ability to distil complex data into actionable insights
Strong project and client management skills, with experience overseeing multiple projects and engaging senior stakeholders
Proven leadership and people management abilities, with a track record of mentoring and developing high-performing teams
Effective communicator with confident presentation skills and the ability to build trusted relationships with clients and colleagues
Experience contributing to business development, including proposal development and client pitches

Job Responsibility

Lead and deliver a diverse portfolio of projects across value communication, evidence synthesis, and HTA
Provide scientific and strategic oversight for the design, execution, and quality assurance of deliverables, including: global value dossiers, payer and reimbursement submissions, systematic and targeted literature reviews (SLRs, TLRs), evidence synthesis and meta-analyses (including ITCs and NMAs)
Translate complex data and analyses into clear, evidence-based narratives aligned with payer and stakeholder needs
Oversee multiple project teams, ensuring deliverables are completed on time, within budget, and to the highest quality standards
Manage project resourcing, timelines, and workload allocation to optimise team performance and impact
Line manage and mentor consultants and analysts, providing technical guidance and supporting professional growth
Foster a high-performance culture focused on collaboration, learning, and continuous improvement
Strengthen team capability in HTA, HEOR, and evidence synthesis methodologies
Collaborate across Valid Insight’s three core pillars—Strategy, Evidence Synthesis, and Value Communication—to deliver integrated, end-to-end market access solutions
Work with cross-functional teams within the Bioscript Group to leverage shared expertise and enhance project delivery

What we offer

Competitive salary package
Flexible and remote working options
Generous annual leave policy which includes a winter shutdown
Birthday charity donation to a charity of your choice
Bonus Day off for community volunteering
Opportunities for professional development and career progression

Fulltime

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

Senior Manager Biostatistics

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 18, 2025

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