Senior Biostatistician

Job Description

The Senior Biostatistician provides statistical input into Phase I – IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results.

The Senior Biostatistician will be responsible for all clinical biostatistical activities in compliance with Standard Operating Procedures (SOPs) and current industry/regulatory guidelines.

Duties and Responsibilities:

• Provide statistical oversight on projects in the assigned drug development programs / projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis and reporting.
• Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program / projects.
• Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
• Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound / therapeutic areas levels.
• Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.
•  Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
• Validate core statistical tables, listings, and figures programmed by statistical programmers and / or biostatisticians, ensuring that core results for each responsible trial are complete and accurate.
• Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.
• Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards / conventions.
• Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement / expectation (e.g. CDISC).
• Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.
• Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Qualifications:

• PhD or Master’s degree in Statistics, Biostatistics,  field, and at least 8 years of biostatistical experience in the clinical trials or health research environment.
• Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
• Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
• Good working knowledge of SAS and CDISC SDTM and ADaM.
• Ability to effectively manage multiple tasks and project, ability to communicate and explain statistics.
• The proven ability to provide leadership and think strategically to achieve business goals.
• Strong analytical, problem solving, and technical skills in database programming.
• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Must be highly organized and self-motivated.

Immediate Joiner

Salary:

• 10,00,000 – 18,00,000 PA

Experience:

• 8 years of biostatistical  in the clinical trials or health research environment.

Location:

• Work From Home

Job Post by #Sanya