Associate Director Biostatistics Job at Amgen (Hyderabad)

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

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, Biostatistical Programming

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
At least 10 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage a large team of programmers
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, and others) or R
Prior regulatory submission experience for approval
Thorough understanding and experience with data quality and compliance checks
Experience working effectively in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and/or high complexity Amgen products
Work with GPL to ensure successful implementation of programming strategies such as functional standards and industry requirements for the assigned products globally
Plan and monitor progress of projects and address issues accordingly
Provide GSP product level input to developing and managing resource plans and budgets for GSP
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
Drive the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Represent GSP in study and system audits and inspections by internal and external bodies
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
Provide hands-on support to the assigned product areas as required

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

Associate Director, Biostatistical Programming

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 10 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage a large team of programmers in successful and timely completion of all programming activities for highly complex studies and regulatory submissions
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, and others) or R
Prior regulatory submission experience for approval
Thorough understanding and experience with data quality and compliance checks
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Prior staff development leadership and project management experience

Job Responsibility

Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and/or high complexity Amgen products being supported by the offshore programming team
Work with GPL to ensure successful implementation of programming strategies such as functional standards and industry requirements for the assigned products globally
Plan and monitor progress of projects and address issues accordingly
Provide GSP product level input to developing and managing resource plans and budgets for GSP
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
Drive the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms to improve functional maturity and efficiency
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Represent GSP in study and system audits and inspections by internal and external bodies
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
Provide hands-on support to the assigned product areas as required

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

Associate Director, Biostatistics

We are seeking an Associate Director of Biostatistics. In this position you will...

Location

United States

Salary:

195000.00 - 215000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in statistics strongly preferred
MS in statistics, biostatistics or mathematics with depth of relevant experience in drug development statistical research will be considered
A minimum of 8 years’ experience in progressive and relevant clinical trial experience
Experience with phase 3 study and regulatory submission is preferred
Experience leading teams and working in a matrix organization
Ability to communicate and work directly with non-statisticians
Excellent communication with an ability to present to a variety of stakeholders
Experience managing CROs and other data vendors
Strong leader with a growth mindset
Ability to keep pace in a fast-moving organization and navigate ambiguity

Job Responsibility

Acting as the statistical lead for one or multiple projects
Providing technical leadership and statistical support on study design, project planning, conduct and execution of clinical studies, and scientific publications
Partnering closely with cross-functional teams
Providing expert biostatistics input on development plans, regulatory interactions, and study design
Authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL
Reviewing study randomization files, ADaM specs, CRF design, DMC charter
Analyzing and interpreting the clinical study results
Ensuring statistical integrity
Contributor on regulatory submissions
Provide expert statistical advice, methodological research and analysis of trial and epidemiological data

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Associate Director / Director, Data Management

Reporting to the Senior Director, Clinical Data Management, the Associate Direct...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS or MS degree in a scientific or health-related field
10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
Proven experience overseeing CROs and external data vendors
Experience developing reports using J-Review and/or other CDM reporting tools
Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization

Job Responsibility

Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
Proactively identify data risks, trends, and operational dependencies
Serve as the primary data management contact for CROs and third-party data vendors
Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml

Fulltime

Associate Director, Breast Oncology Statistical Program

The Statistician in this role will have the title Associate Director of the Brea...

Location

United States , Boston

Salary:

95000.00 - 125100.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

PhD degree in Statistics or Biostatistics and six years of experience required OR Master’s degree in Statistics or Biostatistics and ten years of experience
Experience in oncology and the design and analysis of clinical trials
Knowledge of UNIX/Linux and statistical software such as R or SAS
Expert at statistical methodology, and the use of statistical software, coding, data analysis and effective presentation of results
Comfortable with the statistical literature and able to implement state-of-the-art analytic techniques
Able to construct and implement complex study designs
Understands the nuances of data wrangling and has the ability to use sound principles of reproducible research methods
Adept at performing complex analysis methods and assessing underlying assumptions
Able to lead research teams and/or large projects
Independently discuss and present complex research designs and results to clinical collaborators

Job Responsibility

Routinely directs and supervises data analytic activities of more junior statisticians and/or leads complex projects
Trains, mentors and oversees the design activities of more junior statistical staff
Acts as a key participant in the articulation of the collaborative vision, working with program leaders and clinical research directors on scientific program direction and research portfolio
Independently represents the department on DF/HCC and DFCI committees, including but not limited to Scientific Review Committees (SRC) and Institutional Review Board (IRB)
May direct and/or advise junior statisticians in working with investigators to prepare scientific manuscripts
Expertise in consulting with investigators on all aspects of grant submissions
Work with the grants manager on all administrative aspects, including budget
Advises on the need for more diversified responsibilities, both for themselves and for more junior statisticians who they may supervise
responsible for coordinating statisticians and assuring that investigators are aware of the direct path to statistical assistance
Regularly mentor and advise more junior statisticians in all aspects of their responsibilities and career development

Fulltime

Associate Director, US Real-World Evidence and Health Outcomes – Oncology Pipeline

This Associate Director role supports the US Pipeline Oncology Director in leadi...

Location

United States , Philadelphia; Durham; Collegeville

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Master’s degree or PhD in health economics and outcomes research, epidemiology, public health, biostatistics, or a related discipline
At least 1-3 years of experience the pharmaceutical industry and/or managed care, hospital, academic, or healthcare consulting environment with exposure to HEOR/RWE strategy and application
Know-how regarding the US payer/reimbursement and access environment and familiarity with how payer evidence needs inform evidence planning and deliverables (e.g., value evidence strategy, AMCP-style dossier content, budget impact/cost-effectiveness, payer-focused materials), gained through academic, internship, or professional experience
Expertise in RWE and economic evaluation study designs/methods evidenced by publications and/or contributing to study concept sheets and protocols (including clear research questions, endpoints, data source selection, and bias/confounding mitigation), reviewing/authoring key sections of statistical analysis plans and study reports, and ensuring publication/disclosure readiness in accordance with internal SOPs and external requirements
Strong communication and presentation skills, demonstrated by developing and presenting clear, decision-oriented materials (e.g., evidence strategy slides, executive readouts) and summarizing outcomes/next steps for senior audiences
Proven ability to prioritize, pivot, and manage multiple projects simultaneously in a matrix environment

Job Responsibility

Evidence strategy and planning: Co-develop and maintain US RWE & HO plans for 1–2 priority pipeline assets/indications, aligned to US medical, payer, and access needs
translate strategy into actionable workplans, timelines, and resourcing proposals
Study leadership (RWE/HEOR): Own day-to-day leadership for assigned real-world evidence and health outcomes studies (e.g., real-world evidence studies, cost-effectiveness/budget impact analyses, burden of illness, treatment patterns, patient-focused outcomes) including design and execution in partnership with internal functions and external vendors
Cross-functional stakeholder management: Support the US Pipeline Oncology Director in running cross-functional evidence strategy forums and asset-specific meetings by developing agendas/materials, surfacing options, documenting decisions, and tracking actions to closure
Scientific communication and quality: Draft/review project specifications, protocols, statistical analysis plans, study reports, abstracts, posters, and manuscripts
ensure adherence to SOPs and high scientific/operational quality
Trial design input for US relevance: Provide feedback to Clinical Development and cross-functional teams on optimal trial design to ensure enrollment of US-relevant patient populations and collection of endpoints/outcomes that support US stakeholder needs (e.g., health-related quality of life, patient-reported outcomes, resource utilization, and other health outcomes measures)
Internal decision support: Provide RWE & HO input to internal decision-making during development and commercialization planning (e.g., trial design considerations, data gap assessments, value messages, evidence prioritization and sequencing)
Marketed product support : Contribute ~20% effort to US RWE & HO strategy and execution for a marketed product in endometrial and rectal cancer, including data generation planning, cross-functional alignment, and delivery of analyses/publications that support lifecycle evidence needs and value communication
External insight generation: Maintain strong alignment with Field Based Payer Medical Teams and other field stakeholders to obtain customer insights

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Associate Director Biostatistics

Amgen

Location:
India , Hyderabad

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 18, 2025

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