Associate Director Biostatistics Job at Amgen (Hyderabad)

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, 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

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

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, Epidemiology (Global Health)

Location

United States , Collegeville

Salary:

129000.00 - 179000.00 CAD / Year

GSK

Expiration Date

Until further notice

Requirements

Master’s degree in Epidemiology, Public Health, Biostatistics, or a related quantitative discipline
Epidemiological experience and ability to influence key internal (matrix leaders) and external (e.g. regulators) stakeholders
Experience applying epidemiologic methods in pharmacoepidemiology, clinical development, or outcomes research
Experience designing and delivering observational and database studies, including protocol development and analysis oversight
Experience working in a matrix environment and influencing multidisciplinary teams
Experience providing the delivery of increasingly complex epidemiological studies, including regulatory requirements
Experience applying epidemiology methods and study design knowledge in execution of their work (e.g. post-approval studies)
Experience working with external regulatory requirements and scientific landscape around RWE

Job Responsibility

Accountable for the epidemiology program for at least one asset or disease area, including proposing and negotiating program content and budget with matrix leaders
Provide expert epidemiological insights to asset matrix teams (e.g., Clinical Development Team, Safety Review Team, Medicine/Vaccine Development Team)
Lead complex epidemiological studies and negotiate new partnerships with oversight from senior staff
Identify new vendors, tools, and data sources to deliver innovative epidemiology solutions for assets or disease areas
Contribute to strategic initiatives on the role of epidemiology at the departmental or R&D level
Represent GSK in scientific interactions with internal governance bodies, external regulators, and at international conferences
Plan and coordinate scientific dissemination of epidemiology data, including authoring regulatory documents, peer-reviewed publications, and presentations at national and international meetings
Partner with external groups conducting epidemiological studies globally and manage external collaborations

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

New

Associate Director, Non-clinical Statistician

Provide statistical support for Takeda preclinical campaigns for design and anal...

Location

Japan , Fujisawa

Salary:

Not provided

BioLife Plasma Services

Expiration Date

Until further notice

Requirements

Master's degree or higher in statistics or related field
Good English communication skill in both written and verbal
High level of knowledge, expertise, and experience in biostatistics
High capacity for collecting information
Expert-level knowledge of data science programming languages (SAS, R, Python, or similar) and experience with recommended software development practices
Ability to work independently on complicated datasets, covering all aspects of data analysis
High level of expertise and experience in the pharmaceutical industry
Ability to judge regulatory risk and feasibility
Capacity to build statistical strategies for non-clinical work with fresh perspectives
Preparation for future business domains, such as AI/ML and Real-World Data

Job Responsibility

Lead implementation of SQS strategies and ensure deliverables by representing data science function on project teams in support of preclinical studies throughout the drug discovery units and supporting functions
Perform end-to-end data analyses, from hypotheses formulation, experimental design, writing analysis plans, data cleaning, executing analysis, and preparing reports and documentation
Strengthen Takeda’s advanced analytics toolkit by identifying, promoting, and applying emerging techniques, as well as by developing novel analysis tools as needed
Collaborate effectively within a matrix environment, working with scientists across various areas to understand the problems in terms of its chemistry, biology, and/or physical natures and to tailor data analyses to program-specific needs
Work closely with Takeda statisticians to ensure statistical issues in data analysis are addressed
Communicate internal and external resource and quality issues that may impact deliverables or timelines of the program
Escalate issues to management as appropriate in a timely manner
Respond to regulatory questions that are statistical in nature
Increase the external recognition of Takeda’s data science work by participating in conferences, publishing work and developing external collaborations

What we offer

Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually
Bonus Payment: Twice a year
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Fulltime

Associate Director, Biostatistical Programming

How might you defy imagination? If you feel like you're part of something bigger...

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 16 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

Partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products
Accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products
Contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R&D standards
Lead or serve as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group
Drive the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency across the organization

Fulltime

Clinical Scientist Associate Director

In this role, the Clinical Scientist Associate Director supports the design, exe...

Location

Spain

Salary:

90787.65 - 122830.35 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards
Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments
Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring
Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions
Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable
Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites
Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts
Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees
Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies
Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders

Fulltime

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Associate Director Biostatistics

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