Associate Director-Biostatistics

The Associate Director Biostatistics position based in Ahmedabad requires a candidate with an MSc or PhD in Biostatistics/Statistics and at least 12 years of experience in CROs, Bio-tech, Pharma, or Biopharmaceuticals. As an Associate Director Biostatistics, your main responsibilities will include leading and overseeing all statistical activities for clinical studies. This involves tasks such as study design, analysis plans, reporting, and publications. You will be managing a team of statisticians and programmers to ensure the timely delivery of high-quality work. Additionally, you will provide statistical input on protocols, sample size calculations, and randomization schemes, as well as develop and review statistical analysis plans and related programming. In this role, you will be responsible for interpreting and reporting study data, supporting regulatory responses, and contributing to global submissions. Furthermore, you will play a key role in mentoring and training team members to create a high-performance work environment. You will also represent the company in sponsor meetings, DSMB meetings, and regulatory discussions. The ideal candidate for this position should possess strong leadership, problem-solving, and mentorship skills. Proficiency in statistical tools such as SAS, R, and other software used in life sciences is essential. Experience in regulatory submissions and CDISC standards is also a requirement. Excellent communication, business writing, and presentation skills are crucial for this role, along with the ability to manage multiple projects under tight deadlines. This is a full-time position that requires the candidate to work on-site in Ahmedabad. If you meet the qualifications and are interested in this opportunity, please send your application to maaz@Shamrockvalue.com.,