Associate Director, Biostatistical Programming Job at Amgen (Hyderabad)

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, 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, 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 / 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, 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

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

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Associate Director, Biostatistical Programming

Job Description

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