Website:
thewhiteboard.co.in
Job details:
Job Description for Biostatistician role.
Work location: Remote
Experience: 6+yrs
Notice period: 30days max
Key Responsibilities
- Provide statistical input into study protocols, study design, and sample size calculations.
- Develop Statistical Analysis Plans (SAPs) in accordance with study protocols.
- Perform statistical analysis using SAS/R and generate tables, listings, and figures (TLFs).
- Support interim and final analyses for clinical trials.
- Collaborate with Data Management and Clinical teams to ensure data quality and integrity.
- Review CRFs, datasets, and data specifications.
- Support regulatory submissions (IND, NDA, BLA) with statistical outputs.
- Participate in client meetings and provide statistical insights
Required Qualifications & Experience
- Master’s or PhD in Biostatistics, Statistics, or related field.
- 6+yrs years of experience in clinical trials within CRO or pharmaceutical industry.
- Proficiency in SAS and/or R programming.
- Strong understanding of clinical trial design and statistical methodologies.
- Experience with CDISC standards (SDTM/ADaM) preferred.
- Good knowledge of regulatory guidelines (FDA, EMA, ICH).
- Strong analytical and problem-solving skills.
Below details are required to process your profile for further.
Full Name:
Total Years of Experience:
Inputs to protocol: yrs
Sample size estimation: yrs
Randomization: yrs
Developing SAP: yrs
Reviewing SAP: yrs
Hands on QC Programming Experience: yrs
BioMarker experience: yrs
Real world data evidence experience:
Programming experience in SAS:
Programming experience in R:
Experience in clinical trials within CRO or pharmaceutical industry:
Experience in CDISC standards (SDTM/ADaM) preferred.:
Do you have Strong understanding of clinical trial design and statistical methodologies:
Current Company Name:
Permanent or Contract (If contract mention Payroll company Name):
Current CTC (Mention Fixed + Variables):
Expected CTC:
Holding any offers (Yes / No):
Mention Offered CTC (Fixed + Variable) and location or company):
Notice Period:
Current Location:
Native Place:
Interested in Bangalore Office Based / Hybrid:
Reason for changing the Job:
Availability for Interview(Teams Video Call):
LinkedIn Profile link:
Click on Apply to know more.