Sr. Biostatistician
- Biologics
- Hyderabad
- Clinical Development
This vacancy has now expired. Please see similar roles below...
Review Scientific and business requirements to propose appropriate and efficient statistical designs for clinical studies, both premarketing and post marketing including the calculation of sample sizes conciliating the need to provide valid results with those of keeping a reasonable study size.
Helps in the interpretation of scientific literature, notably in aspects relating to its numerical validity, limitations and in the adaption of the results for use in study design and general decision making. Supporting in preparation of clinical scientific meeting requirements.
Conduct clinical trial simulations to optimize the selection of clinical trial endpoints, statistical analysis methods and clinical trial design.
Provide expertise and guidance in clinical study design and implement efficient and effective practices in the execution and analysis of clinical trials.
Preparation and review of relevant statistical sections of Clinical trial outline document and protocols.
Review of Case Report Forms (CRF) /eCRF.
Review of other data management related documents.
Review and providing inputs for Clincial study report for statistical conclusions and interpretations.
Collaborate effectively with internal and external teams to support and resolve the statistical issues.
Preparation and Review of Randomization plans.
Review of dummy randomization and IWRS/IVRS guidelines.
Preparation and review of Statistical Analysis Plans(SAP).
Providing statistical support in analyzing the data as per SAP.
Review and preparation of mock Tables, Listings and figures.
Providing inputs for Data Cleaning and assisting data clean meetings.
Preparing and reviewing Blinded Data review (BDRM/DRM) rules and setting up meetings to finalize the analysis populations.
Oversee of statistical analysis programming, validation and analysis of clinical trials.
Review of Key TFL and providing summaries on key study outcomes.
Oversee, review and finalization of of study tables, listings and figures.
Performe Interim analysis and review of sample size re-estimations.
Provides statistical analyses for decision making, regulatory submissions and interactions with regulatory agencies.
Interpreting the results and and presenting the results and summaries.
Prepares reports that summarize the analysis, interprets the findings and provides conclusions and recommendations including statistical analyses for decision making, regulatory submissions and resolving regulatory queries.
Review of SDTM and ADaM as per CDISC standards.
Mandatory Skills
knowledge of SAS, R and other relevant statistical software's. Understanding data management principles for clinical trials and medical research. in depth understanding of statistical theory and modeling. strong analysis and interpretation skills.
Strong knowledge of statistics including experimental and clinical trial design, linear and mixed statistical models, non-parametric statistics, logistic and poison regression, longitudinal data analysis, and categorical data analysis. Therapy Areas; Diseases; Treatment options; Technology Platforms, Delivery systems, basics of clinical development
MAsters in Statistics/Biostatistics
Close to 15 years of experience in Pharma industry handling clinical trials
Latest jobs
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Internal Audit
Business Unit
Corporate
Location
Hyderabad
Description
Job summaryWe are looking to hire a Lead - Data Analytics team ensuring continuous control monitoring, risk based insights for proactive management and higher risk oversight. Responsibilities include
Reference
57337858-91be-4748-88f3-5d50a6fac842
Expiry Date
01/01/0001
Salary
Location
Princeton
Type of Working
Full Time
Job Family
Intellectual Property Management
Business Unit
NAG
Location
Princeton
Description
We are seeking an Intellectual Property (IP) Counsel to join our Princeton, NJ office . This role will report directly to the Head of Intellectual Property for North America As an Attorney in the IP
Reference
fd1c9d70-7a91-4eec-a1e6-1fe575dce308
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Process Engineering - API
Business Unit
IPDO
Location
Pydibimavaram
Description
Job Summary We are seeking a dynamic and experienced CPP Production team member in Active Pharmaceutical Ingredient (API) to support the development of robust and cost-effective API's by executing s
Reference
82598d63-cf0c-418e-9124-0269c9eb9630
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Quality Control
Business Unit
GMO
Location
Pydibimavaram
Description
Education : BS.c/ M.ScExp : 2-6 Years Operation and calibration of Spraytec and spray view instrument. Analysis of Assay and Related substances test of Nasal product.Determination of particle size by
Reference
525b8a47-867f-4417-9da5-608dd0b63c57
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Portfolio Management
Business Unit
GMO
Location
Hyderabad
Description
JOB SUMMARY:Incumbent will be part of the Central Portfolio Organization which is responsible for Global Portfolio Management & Strategic planning for Dr. Reddy's. The major responsibilities associate
Reference
80ad30e5-6144-49fd-bcee-34c597956dfd
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Operation, Repair & Maintenance
Business Unit
GMO
Location
Pydibimavaram
Description
Job Summary Roles & Responsibilities:Hands on experience of Overall Asset care for Process equipment to take care of the total process equipment health of the plant.For OSD/Encapsulation/Ointment/QCOS
Reference
d2681c38-6aa2-4623-83c8-868131302758
Expiry Date
01/01/0001
Salary
Location
Princeton
Type of Working
Full Time
Job Family
Supply Chain Planning
Business Unit
NAG
Location
Princeton
Description
We are seeking a Lead Associate Supply Chain Planner to join us at our Princeton office, ensuring inventory planning for all Rx and Srx products meets market demands. You will collaborate closely with
Reference
16ddac64-d827-4cd7-934b-23d0a7b3a2a1
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Analytical R&D - OSD
Business Unit
IPDO
Location
Hyderabad
Description
Job SummaryWe are seeking an experienced Lead in analytical development who can plan and execute Method development and method validations. Knowledge in EM countries regulatory requirements including
Reference
a7f10ec3-d7bf-49bc-ab7c-20d2dc531700
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Clinical Development
Business Unit
Biologics
Location
Hyderabad
Description
QC and formatting of clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), investigator’s brochures (IBs), and clinical data summaries for phase 1-phase 3 and post-ma
Reference
d9f94004-1363-4571-bd1f-8345ebb03c44
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Technology Transfer - OSD
Business Unit
IPDO
Location
Pydibimavaram
Description
We are seeking a detail-oriented and analytical Team Member to join our Manufacturing Science and Technology (MSAT) team in Pydibimavaram, India. As an MSAT Team Member, you will play a crucial role i
Reference
eb6372a7-4bd3-4ef7-8a7d-18fe9c859dac
Expiry Date
01/01/0001
Jobs you have shown an interest in