Sr. Manager -- Biostatistics and SAS programming
Job responsibilities:
Manage the team of Biostatisticians and SAS programmers for delivering Clinical Trial reports.
Overall management of clinical trial analysis as per GCP standards which include the following:

Statistical inputs to protocol planning, sample size estimation, preparation and approval of statistical analysis plan, inputs to costing and timelines estimation, inputs to CRF preparation, generating outputs as per specifications using SAS, validation, and delivering projects as per agreed timelines without any errors in the program or reports.

• Recruiting and retaining talents
• Planning and execution of projects and pipeline
• Coordinating with medical affairs and clinical data management team for effective execution of projects
• Participation in client meetings for capability presentation, business development etc.

Skill set:

• Must have a post graduate degree in Statistics/Biostatistics though Ph.D. is desirable
• Minimum 8 -10 years of experience of which 5-6 years of experience should be handling statistical reporting of clinical trials in a CRO setup or a big pharma company especially in an MNC with global exposure.
• Should have handled Phase I to IV clinical trials for any FDA/EU submissions.
• Good exposure to SAS programming for clinical trials especially in a regulated environment
  
• Exposure to PK (BA/BE) studies will be an added advantage
  
• Good communication skills both written and verbal is a must.
  
• Project management skills.

Team lead:
Skill Set:
SAS programming + Statistics PG degree + Man Management Min exp: 3-4 Years CR industry/CRO.

Senior Statistician:
Skill Set: PhD./ Statistics PG degree Min exp: 2 Years CR industry/CRO.

Statistician
Skill Set: Statistics PG degree Min exp: 1 Years.

Senior SAS Programmer
Skill Set: SAS Programmer + SAS Certified Min exp: 2 Years CR industry/CRO.

SAS Programmer
Skill Set: SAS Programmer + SAS Certified Min exp: 1-2 Years.

All the above positions are based at Gurgaon.