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
OPEN POSITIONS
Latest jobs
Location
Hyderabad
Salary
Type of Working
Full Time
Job Family
Clinical Operation
Business Unit
Biologics
Location
Hyderabad
Description
Job Summary We are seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic grou
Reference
cc8891bf-220e-4dd9-96ca-160c92fd7140
Expiry Date
01/01/0001
Location
Hyderabad
Salary
Type of Working
Full Time
Job Family
Production - API
Business Unit
GMO
Location
Hyderabad
Description
Job Summary We are seeking a dynamic and experienced Leader in Operational Excellence for overseeing the implementation of an operational framework, optimizing organizational processes through data
Reference
8f528466-b0f2-4dbc-93c5-84ad5aad7ba6
Expiry Date
01/01/0001
Location
Hyderabad
Salary
Type of Working
Full Time
Job Family
Accounting
Business Unit
Corporate
Location
Hyderabad
Description
Job summary Roles & Responsibilities Review and Preparation of monthly operating expenses to understand and check accounting accuracy, hygiene of balance sheet line items on periodical basis.Enab
Reference
89ac83ec-a880-4df8-913d-a36839ff36c8
Expiry Date
01/01/0001
Location
Pydibimavaram
Salary
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
Location
Pretoria
Salary
Type of Working
Full Time
Job Family
Sales General
Business Unit
GG EM
Location
PRETORIA
Description
RoleThe job incumbent will be responsible for the following: Selling, detailing and promoting products, in a designated area, to targeted private sector clients.Assisting with the organizing and pr
Reference
008d4bb9-e698-4a9e-9a47-a57dd2569c92
Expiry Date
01/01/0001
Location
Hyderabad
Salary
Type of Working
Full Time
Job Family
Quality Assurance
Business Unit
GMO
Location
Hyderabad
Description
To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing.To Involve in valid O
Reference
18c742d9-528b-412b-b274-6795b96a6881
Expiry Date
01/01/0001
Location
Hyderabad
Salary
Type of Working
Full Time
Job Family
Formulation R&D - OSD
Business Unit
IPDO
Location
Hyderabad
Description
Job Summary We are seeking a dynamic and experienced Specialist in Formulation Development team responsible for execution and development of Oral Solid/Liquid formulations as per project timelines,
Reference
9ed5f788-9ef2-4fa7-a177-9e22480cfa54
Expiry Date
01/01/0001
Location
Bengaluru
Salary
Type of Working
Full Time
Job Family
Medical Affairs & Information
Business Unit
GG INDIA
Location
Bengaluru
Years of experience
0 - 1
Description
Job Summary We are looking for the Primary scientific face of the organization to ‘Thought Leaders’ & physicians for a given therapy area. You will be responsible for Identification, mapping and prof
Reference
ef5a73a8-5664-4778-8202-38f8249113ec
Expiry Date
01/01/0001
Location
Baruipur
Salary
Type of Working
Full Time
Job Family
Sales General
Business Unit
GG INDIA
Location
Baruipur
Description
Job Summary We are seeking an experienced and dynamic individual for the position of “Territory Sales Executive” for achieving sales targets, promoting pharmaceutical products, and building strong r
Reference
ff071df5-7526-4a78-851d-eea1ef83d664
Expiry Date
01/01/0001
Location
Hyderabad
Salary
Type of Working
Full Time
Job Family
Financial Planning & Analysis
Business Unit
IPDO
Location
Hyderabad
Description
Job SummaryThe person responsible will lead planning agenda working closely with his/her team. Primary area of involvement will be to work closely with (a) development teams wrt R&D Budget. Forecasti
Reference
c41aff00-0054-49c8-a467-33e1c80c5742
Expiry Date
01/01/0001
OPEN POSITIONS
Jobs you have shown an interest in