Biostatistician/Manager - Stats Programmer - SAS + SDTM Programmer

We have urgent requirement for one of top "CRO" MNC

Experience required: 3 +Years into Biostatistician/Manager Stats Programmer/ SAS + SDTM Programmer

Work Location: Mumbai/Bangalore

Salary: Best in Industry

JOB DESCRIPTION

PURPOSE

Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.

RESPONSIBILITIES

Manager Stats Programmer:

1. Clinical domain Knowledge,

2. Base SAS and macro experience,

3. Communication Skills

4.Perform project management

5. Perform People Management

Bio statistician:

1)Clinical Domain Knowledge

2) Statistics skills i.e., SAP creation, randomization, sample size calculation

3)Safety and Efficacy data analysis

4) Protocol Inputs

5) Statistical Review

6) Project Management exp

7) Training and Mentoring individuals with 8) M.Sc. statistics background with exposure on biostatistics as well as programming skills (combination profile), since individual has to take further STL role and also contribute in some efficacy programming activities.

SAS + SDTM Programmer:

1) Clinical Domain Knowledge

2) SAS programming experience.

3) SDTM and ADaMs and TLFs experience

4) Phase 1 studies exposure is advantage

5)Ability to assist/Perform project management.

1)Clinical Domain Knowledge

2) Statistics skills i.e.,SAP creation & review, randomization, sample size calculation

3)Safety and Efficacy data analysis

4) Protocol developments Inputs

5) Statistical Review

6) Project Management exp

7) Training and Mentoring

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

- Excellent written and oral communication skills including grammatical/technical writing skills

- Excellent attention and accuracy with details

- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials

- Familiarity with moderately complex statistical methods that apply to applicable clinical trials

- Strong individual initiative

- Strong organizing skills

- Strong working knowledge of SAS computing package

- Familiarity with other relevant statistical computing packages such as nQuery

- Strong commitment to quality

- Ability to effectively manage multiple tasks and projects

- Ability to lead and co-ordinate small teams

- Ability to solve moderately complex problems

- Ability to establish and maintain effective working relationships with coworkers, managers and clients

- Working knowledge of relevant Data Standards (such as CDISC/ADaM)

Interested candidate kindly share your updated resume attaching your photograph also

Awaiting your kind revert.

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