Clinical SAS Programmer & Biostatistician

Location:- Bangalore and Mumbai

SAS Programmer

RESPONSIBILITIES

- Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing, (ii) the programming of analysis dataset (derived datasets) and transfer files for internal and external clients. and (iii) the programming quality control checks for the source data and report the data issues periodically.

- Detect errors in detail, corrects them (e.g., reviews tables/listings, edit checks output and SAS programs to ensure quality of deliverable) and report it to appropriate personals (internal or external clients)

- Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department.

- Perform and plan the development, implementation and validation of new process technologies, macros and applications.

- Fulfill project responsibilities at the level of technical team lead for single studies, under supervision.

- Understand timelines for and milestones affecting their work and alert supervisor to potential slippage.

- Provide training and mentoring to SP team members

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

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

- Knowledge of statistics, programming and/or clinical drug development process

- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

- Ability to implement programming specifications, as appropriate

- Ability to estimate programming scope of work and assist in communicating project status

- Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language

- Exhibits routine and occasionally complex problem solving skills

- Recognizes when negotiating skills are needed and seeks assistance.

- Good organizational, interpersonal, leadership and communication skills

- Ability to effectively handle multiple tasks and projects, under supervision

- Excellent accuracy and attention to detail

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

BIOSTATISTICIAN

RESPONSIBILITIES

- Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.

- Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.

- Advise data management staff on database design, and critical data. May advise on validation checks.

- Write statistical sections of integrated reports.

- Under supervision, act as statistical team lead for single studies.

- understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for single studies. May manage project budget and resource requirements and provide revenue and resource forecasts for single studies.

- Assist with review of RFPs and QIPs; prepare proposal text. May participate in bid defense meetings.

- Provide training and guidance to lower level and new staff.

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

- Strong individual initiative

- Strong organizing skills

- Strong working knowledge of SAS computing package

- Familiarity with other relevant statistical computing packages such as StatXact

- Strong commitment to quality

- Ability to effectively manage multiple tasks and projects

- Ability to provide and accept direction of lead team members

- 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)