Biostatistician - ADaM and SDTM

To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email deepak.arya@collabera.com. Thank you!

Pay Range: $60 to $70 an hour. 

Client Industry: Pharmaceutical 

Job Mode: Remote

Contract Duration: 3 Months Contract, with potential extension based on performance and business

Job Summary:

We are seeking an experienced Biostatistician III to lead statistical planning, analysis, and interpretation for clinical development programs. The role requires strong expertise in clinical trial design, statistical methodology, and statistical computing to support drug development activities. The successful candidate will develop, validate, and implement statistical analyses and simulation studies. This position involves collaborating with clinical teams and overseeing statistical programming activities to ensure accurate, reliable, and regulatory compliant results.

Key Responsibilities:

• Lead statistical planning, clinical trial design, analysis, and interpretation across clinical development programs.


• Develop, validate, and implement statistical methods and simulation studies to support clinical research.


• Apply statistical techniques including ANCOVA, multiple imputation, multiplicity control, Type I error control, and power calculations.


• Oversee internal and external statistical programming activities related to clinical programs.


• Support statistical analysis and programming for Phase I, Phase II, and Phase III clinical trials.


• Interpret statistical results and communicate findings to cross functional teams.


• Ensure statistical methods and analyses align with applicable drug development regulations and regulatory submission requirements.

Required Qualifications:

• Master's degree or PhD in Statistics or Biostatistics, with a PhD preferred.


• 5 to 7 years of experience in the pharmaceutical or biotechnology industry.


• Experience serving as the primary statistician for at least one NDA or BLA submission.


• Experience preparing statistical analysis programs for Phase I through Phase III clinical trials.


• Proficiency in at least one of R, SAS, or Python.


• Strong understanding of statistical theory, clinical trial design, statistical computing, and data interpretation.


• Hands on experience with statistical analyses and simulation studies, including ANCOVA, multiple imputation, multiplicity control, Type I error control, and power calculations.


• Knowledge of drug development regulations related to clinical trial design and statistical analysis.


• Excellent technical writing, communication, analytical, and collaboration skills.

Preferred Qualifications:

• PhD in Statistics or Biostatistics.


• Experience using multiple statistical programming languages, including R, SAS, and Python.


• Advanced experience in statistical simulations and clinical trial methodology.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long term disability insurance, short term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)