Associate Director, Biostatistical Programming Job at Amgen (Hyderabad)

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

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 / 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, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

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Associate Director, Biostatistical Programming

Job Description

Job Responsibility

Requirements

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What we offer

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