Assistant Manager - Biostatician

Location: Hyderabad, Corporate Office

Job Type: Full-Time

Collaborating with cross-functional teams (e.g., clinical researchers, medical experts, data scientists) to design clinical studies and research protocols.

• Developing statistical analysis plans (SAP), including the identification of primary and secondary endpoints, sample size calculations, and statistical methodologies.
• Ensuring statistical methods are aligned with regulatory requirements and industry standards, especially in clinical trials.
• Providing expertise on randomization techniques and adaptive designs.
• Leading the analysis of complex datasets, including data from clinical trials, epidemiological studies, and observational studies.
• Ensuring proper data cleaning, transformation, and validation processes are followed to guarantee the integrity of the data.
• Using advanced statistical software and techniques (e.g., R, SAS, STATA) to perform statistical modelling (e.g., regression models, survival analysis, mixed models).
• Analyzing and interpreting results, ensuring conclusions are scientifically sound, and communicating findings in a clear, concise manner.
• Developing and applying advanced statistical methodologies and techniques tailored to specific study needs, such as longitudinal analysis, survival analysis, or Bayesian methods.
• Assessing and adapting statistical methods as necessary based on emerging data or evolving study designs.
• Participating in regulatory meetings and discussions, providing statistical justification for study results and approaches.
• Mentoring and providing guidance to junior biostatisticians and other team members on statistical methodologies, software, and best practices.
• Developing training materials and conducting workshops on statistical topics for internal teams and collaborators.
• Ensuring statistical methods and processes are consistent with industry best practices and organizational standards.
• Conducting quality control procedures on statistical analyses to verify results and ensure accuracy and validity.
• Preparing statistical reports, manuscripts, presentations, and posters for scientific journals, conferences, and internal stakeholders.
• Clearly presenting complex statistical results to non-statistical audiences (e.g., clinical or regulatory teams), ensuring the results are understood and actionable.
• Working closely with other teams, including clinical researchers, project managers, and data scientists, to ensure the alignment of statistical analyses with research objectives.
• Actively participating in meetings, strategy sessions, and research reviews to provide statistical insights that can influence study direction and design.
• Translating statistical findings into actionable recommendations for decision-making.
• Ensuring that statistical analyses comply with ethical standards and regulatory requirements (e.g., Good Clinical Practice (GCP), Good Statistical Practice (GSP)).
• Supporting the development of ethical guidelines for statistical methodologies, including ensuring patient safety and data confidentiality.

Additional Skills:

SAS Programming

R Programming (Optional)

Advanced knowledge of biostatistics, including statistical theory, methods, and applications.

• Proficiency in statistical software such as SAS, R, and STATA.
• Strong communication skills, especially in translating complex statistical concepts into practical recommendations.
• Attention to detail and the ability to ensure the quality and accuracy of analyses.
• Experience with clinical trials and regulatory submissions is often critical.

Qualifications:

Master & Degree (Preferred):

A Master in Biostatistics, Statistics, Public Health, or a related field is commonly required for many biostatistician roles, especially in CRO, research institutions, pharmaceutical companies, or public health organizations.

Interested Candidates please send me resumes to Pitchireddy.t@hetero.com

Best Regards

Pitchireddy

Corporate HR