Biostatistical Programming Manager Job at Amgen

Senior Manager 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

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Vast opportunities to learn and develop within 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

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

Program Manager II, Biostatistics and Data Science

Under administrative review, performs management level work directed toward the ...

Location

United States , Winston Salem

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor's degree and three years of relevant experience or equivalent combination
Master's degree in Health Administration, Business Administration or related field preferred
Three years' experience in project management, program management development, administration or supervisory experience required
Excellent oral and written communication skills
Previous supervisory experience
Solid interpersonal skills to effectively build relationships with business partners across departments and facilitate work among teams
Strong analytical and critical thinking skills
Strong PC background in computer spreadsheets systems and presentation packages
Skilled problem solver who can work independently
Ability to manage special projects, work under pressure, meet deadlines

Job Responsibility

Manages and oversees the planning, implementation, coordination and evaluation of major projects
Assumes major responsibility for coordinating the successful and timely completion of the tasks within projects
Manages and/or implements all operational policies and procedures related to the functioning of the program
Prepares periodic analyses and reports reflecting progress and trends of on-going projects/programs
Tracks, evaluates, and interprets collected financial data
Manages the preparation of progress reports and quality control monitoring
Participates in the analysis of study data and the writing of sponsor progress and financial reports
Assists in the administration of the departmental budget by tracking expenditures and performing other financial tasks
Assumes responsibility for the outcome of the program(s)
Assists and supervises support personnel

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Opportunity for annual increases based on performance
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions

Fulltime