ASSOCIATE STATISTICIAN - MUMBAI / BANGALORE / HYDERABAD

Statistics & Decision Sciences Quantitative Sciences, R&D Operations Position Summary The Associate Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen.
Activities associated with the role will require guidance from managers and project statisticians.
He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals.
Lead, Shape, Connect, and Deliver.
Position Core Competencies, Responsibilities and Accountabilities Expertise.
Ensures application of appropriate statistical methods and generation of accurate and reproducible results.
Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
Quality and Compliance.
Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting.
Understands and aligns with relevant regulatory guidances.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards.
Follows best practices for Data Integrity.
Drug Development.
Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support.
Is accountable for the execution of individual project responsibilities, including.
meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
Collaboration.
Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management.
Programming.
Has a working knowledge of SAS or R, as well as other relevant computational tools as required.
External Engagement.
Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.
Process.
Basic knowledge of data architecture and formats, such as Data Standards.
Area Specific Core Competencies, Responsibilities and Accountabilities These are additional to the above position core competencies, applicable to individuals according to their assigned area within Statistics & Decision Sciences.
Discovery & Translational Manages multiple projects.
Documents projects in sufficient detail for reproducibility.
Statistical Modeling & Methodology Not Applicable.
Manufacturing & Toxicology Manages multiple projects.
Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories.
Medical Affairs Not Applicable.
Real World Evidence Not Applicable.
Supervision and Reporting Relationships This position reports to a Director or above, and is an individual contributor position.
Interfaces Internal.
Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance.
External.
Contracted Partners, Academia, Professional Societies.
Qualifications Statistics & Decision Sciences Quantitative Sciences, R&D Operations Pay Grade, Position Title Pay Grade 24 Associate Statistician Position Summary The Associate Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen.
Activities associated with the role will require guidance from managers and project statisticians.
He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals.
Lead, Shape, Connect, and Deliver.
Position Core Competencies, Responsibilities and Accountabilities Expertise.
Ensures application of appropriate statistical methods and generation of accurate and reproducible results.
Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
Quality and Compliance.
Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting.
Understands and aligns with relevant regulatory guidances.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards.
Follows best practices for Data Integrity.
Drug Development.
Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support.
Is accountable for the execution of individual project responsibilities, including.
meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
Collaboration.
Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management.
Programming.
Has a working knowledge of SAS or R, as well as other relevant computational tools as required.
External Engagement.
Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.
Process.
Basic knowledge of data architecture and formats, such as Data Standards.
Area Specific Core Competencies, Responsibilities and Accountabilities These are additional to the above position core competencies, applicable to individuals according to their assigned area within Statistics & Decision Sciences.
Discovery & Translational Manages multiple projects.
Documents projects in sufficient detail for reproducibility.
Statistical Modeling & Methodology Not Applicable.
Manufacturing & Toxicology Manages multiple projects.
Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories.
Medical Affairs Not Applicable.
Real World Evidence Not Applicable.
Supervision and Reporting Relationships This position reports to a Director or above, and is an individual contributor position.
Interfaces Internal.
Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance.
External.
Contracted Partners, Academia, Professional Societies.
Education and Experience Requirements Master’s Degree in Statistics or related field plus 0–2 years minimum relevant experience.
Basic knowledge of SAS or R programming.
Good written, oral, and interpersonal communication skills.