They are looking for a Senior Biostatistician to strengthen its Biometrics teams.
Responsibilities include
Author the Statistical Sections of Protocol.
Propose and Review the Study design.
Calculate the sample size.
Review the Case Report Form (CRF).
Review the Edit Check Document (specifically for critical modules like RECIST 1.1 etc.).
Write the randomization specifications and coordinate and finalize all the randomization activities with the IWRS vendor.
Author Statistical Analysis Plan (interim and final as appropriate).
Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS.
Ensure quality of all the outputs developed.
Perform the role of validator as appropriate.
Provide Statistical Consultancy on an ongoing basis for projects.
Perform Futility and Efficacy analysis as appropriate for interim analysis and interact with third party independent Statistician.
Provide inputs to the regulatory affairs for all the discussions with the health authorities (e.g. ANSM, EMA, FDA).
Review the Clinical Study Report and provide statistical inputs as appropriate.#
Background
Ph.D. in Statistics with minimum 3 years of relevant pharmaceutical (or CRO) industry work experience or Masters in Statistics or equivalent with minimum 5 relevant pharmaceutical (or CRO) industry work experience.
Good Knowledge of SAS.
Preliminary working knowledge on R.
Good Understanding of CDISC Concepts.
Good understanding of ICH guidelines.
Strong written and verbal English communications skills.
